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1.
Qual Life Res ; 33(6): 1555-1567, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38507142

ABSTRACT

PURPOSE: Rasch analysis and exploratory factor analysis (EFA) were used to evaluate the structural validity of the ASCOT-Proxy measures completed by staff on behalf of older adults resident in care homes, by comparison to the ASCOT-SCT4, the measure of social care-related quality of life (SCRQoL) from which the ASCOT-Proxy was developed. METHODS: EFA was conducted on the ASCOT-SCT4 and the two ASCOT-Proxy measures (Proxy-Proxy, Proxy-Resident), to determine if they retained the single factor of the original ASCOT-SCT4 measure found in samples of older community-dwelling adults. Rasch analysis was also applied to measures with a single factor structure in the EFA. RESULTS: ASCOT-Proxy-Resident had a single factor structure, as did the original ASCOT-SCT4 (also, found in this analysis when completed by care home staff). The ASCOT-Proxy-Proxy had a two factor structure. Rasch analysis of ASCOT-Proxy-Resident and ASCOT-SCT4 had an acceptable model fit, internal consistency and met the assumptions of unidimensionality and local independence. There was evidence of less than optimal distinguishability at some thresholds between responses, and low frequency of rating of the 'high level needs'. CONCLUSION: The ASCOT-Proxy-Resident is a valid instrument of SCRQoL for older adults resident in care homes, completed by staff proxies. Due to the two-factor structure, which differs from the original ASCOT-SCT4, we do not recommend the use of the ASCOT-Proxy-Proxy measure, although collecting data as part of the ASCOT-Proxy questionnaire may support its feasibility and acceptability. Further qualitative study of how care home staff complete and perceive the ASCOT-Proxy is encouraged for future studies.


Subject(s)
Proxy , Psychometrics , Quality of Life , Humans , Male , Female , Aged , Factor Analysis, Statistical , Surveys and Questionnaires/standards , Aged, 80 and over , Reproducibility of Results , Nursing Homes , Middle Aged , Adult , Homes for the Aged
2.
BMJ Open ; 14(2): e075273, 2024 02 01.
Article in English | MEDLINE | ID: mdl-38307536

ABSTRACT

INTRODUCTION: Many people living with dementia experience sleep disturbance and there are no known effective treatments. Non-pharmacological treatment options should be the first-line sleep management. For family carers, relatives' sleep disturbance leads to interruption of their sleep, low mood and breakdown of care. Our team developed and delivered DREAMS START (Dementia RElAted Manual for Sleep; STrAtegies for RelaTives), a multimodal non-pharmacological intervention, showing it to be feasible and acceptable. The aim of this randomised controlled trial is to establish whether DREAMS START is clinically cost-effective in reducing sleep disturbances in people living with dementia living at home compared with usual care. METHODS AND ANALYSIS: We will recruit 370 participant dyads (people living with dementia and family carers) from memory services, community mental health teams and the Join Dementia Research Website in England. Those meeting inclusion criteria will be randomised (1:1) either to DREAMS START or to usual treatment. DREAMS START is a six-session (1 hour/session), manualised intervention delivered every 1-2 weeks by supervised, non-clinically trained graduates. Outcomes will be collected at baseline, 4 months and 8 months with the primary outcome being the Sleep Disorders Inventory score at 8 months. Secondary outcomes for the person with dementia (all proxy) include quality of life, daytime sleepiness, neuropsychiatric symptoms and cost-effectiveness. Secondary outcomes for the family carer include quality of life, sleep disturbance, mood, burden and service use and caring/work activity. Analyses will be intention-to-treat and we will conduct a process evaluation. ETHICS AND DISSEMINATION: London-Camden & Kings Cross Ethics Committee (20/LO/0894) approved the study. We will disseminate our findings in high-impact peer-reviewed journals and at national and international conferences. This research has the potential to improve sleep and quality of life for people living with dementia and their carers, in a feasible and scalable intervention. TRIAL REGISTRATION NUMBER: ISRCTN13072268.


Subject(s)
Caregivers , Dementia , Humans , Cost-Benefit Analysis , Caregivers/psychology , Quality of Life , Dementia/complications , Dementia/therapy , Sleep , Randomized Controlled Trials as Topic , Multicenter Studies as Topic
3.
Nat Med ; 30(2): 403-413, 2024 Feb.
Article in English | MEDLINE | ID: mdl-38228914

ABSTRACT

Disruption in reciprocal connectivity between the right anterior insula and the left dorsolateral prefrontal cortex is associated with depression and may be a target for neuromodulation. In a five-center, parallel, double-blind, randomized controlled trial we personalized resting-state functional magnetic resonance imaging neuronavigated connectivity-guided intermittent theta burst stimulation (cgiTBS) at a site based on effective connectivity from the right anterior insula to the left dorsolateral prefrontal cortex. We tested its efficacy in reducing the primary outcome depression symptoms measured by the GRID Hamilton Depression Rating Scale 17-item over 8, 16 and 26 weeks, compared with structural magnetic resonance imaging (MRI) neuronavigated repetitive transcranial magnetic stimulation (rTMS) delivered at the standard stimulation site (F3) in patients with 'treatment-resistant depression'. Participants were randomly assigned to 20 sessions over 4-6 weeks of either cgiTBS (n = 128) or rTMS (n = 127) with resting-state functional MRI at baseline and 16 weeks. Persistent decreases in depressive symptoms were seen over 26 weeks, with no differences between arms on the primary outcome GRID Hamilton Depression Rating Scale 17-item score (intention-to-treat adjusted mean, -0.31, 95% confidence interval (CI) -1.87, 1.24, P = 0.689). Two serious adverse events were possibly related to TMS (mania and psychosis). MRI-neuronavigated cgiTBS and rTMS were equally effective in patients with treatment-resistant depression over 26 weeks (trial registration no. ISRCTN19674644).


Subject(s)
Depressive Disorder, Treatment-Resistant , Transcranial Magnetic Stimulation , Humans , Double-Blind Method , Magnetic Resonance Imaging/methods , Prefrontal Cortex/diagnostic imaging , Transcranial Magnetic Stimulation/adverse effects , Transcranial Magnetic Stimulation/methods , Treatment Outcome , Depressive Disorder, Treatment-Resistant/therapy
4.
Int Psychogeriatr ; 36(4): 263-288, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38053362

ABSTRACT

OBJECTIVE: This systematic review identified key components of risk assessment for people with dementia, examined attitudes toward risk identification and risk assessment, and appraised existing risk assessment tools. METHODS: Systematic searches of five databases on two platforms (EBSCO, OVID) and gray literature databases (Open Grey, Base) were conducted. Studies were screened for inclusion based on predetermined eligibility criteria and quality assessed using the Mixed Methods Appraisal Tool. Findings were tabulated and synthesized using thematic synthesis. RESULTS: Our review found people with dementia, their family carers, and healthcare professionals differed in how risk is conceptualized, with views being shaped by media perceptions, personal experiences, socio-cultural influences, dementia knowledge, and dementia severity. We found that mobilization (causing falls inside and getting lost outside) is the most frequently identified risk factor. Our findings show people with dementia are generally risk-tolerant, while healthcare professionals may adopt risk-averse approaches because of organizational requirements. We found factors that disrupt daily routines, living and caring arrangements, medication management, and unclear care pathways contribute toward adverse risk events. We discovered that most studies about risk and risk assessment scales did not consider insight of the person with dementia into risks although this is important for the impact of a risk. No risk instrument identified had sufficient evidence that it was useful. CONCLUSION: Accurate risk assessment and effective communication strategies that include the perspectives of people with dementia are needed to enable risk-tolerant practice. No risk instrument to date was shown to be widely acceptable and useful in practice.


Subject(s)
Caregivers , Dementia , Humans , Health Personnel , Risk Assessment
5.
J Med Imaging Radiat Sci ; 54(2S): S95-S103, 2023 06.
Article in English | MEDLINE | ID: mdl-37019815

ABSTRACT

PURPOSE: There has been little research providing an in-depth exploration of the reasons behind research participants, particularly in mental health settings, requesting copies of their research data, such as magnetic resonance imaging (MRI) scans. BRIGhTMIND is a large double blind randomised controlled trial using functional and structural magnetic resonance imaging to create personalised targets for transcranial magnetic stimulation delivery, and a number of trial participants requested copies of these scans. METHODS: Seven participants involved in the BRIGhTMIND trial completed semi-structured interviews exploring their reasons behind their request for copies of their MRI scans. The qualitative data was co-analysed between researchers and patient and public involvement and engagement representatives using inductive thematic analysis. RESULTS: The interviews produced consistent themes concerning curiosity to visualise their MRI scans, and the hope that their participation would result in a better understanding of the nature and future treatment of depression. Concerns around the rights to access their own personal health data emerged as a clear theme as did their own ability to interpret any radiological information. DISCUSSION: This study provides insight into the reasons why research participants with depression would like to retain copies of their MRI scans and the perceived role that such techniques may have for improving research and neuromodulation treatments in depression. Such first-hand experiential accounts emphasises the importance of listening to participants perspectives and lived experience, in order to improve research and health outcomes. Future research could aim to provide greater verbal and written information for participants, including details about the accessibility to their MRI scans, the difference between research and clinical MRI scans, and educational materials to help with the interpretation of MRI images.


Subject(s)
Depression , Transcranial Magnetic Stimulation , Humans , Brain/diagnostic imaging , Magnetic Resonance Imaging , Radiography
6.
BMJ Open ; 13(2): e071686, 2023 02 27.
Article in English | MEDLINE | ID: mdl-36849214

ABSTRACT

INTRODUCTION: Health and care data are routinely collected about care home residents in England, yet there is no way to collate these data to inform benchmarking and improvement. The Developing research resources And minimum data set for Care Homes' Adoption and use study has developed a prototype minimum data set (MDS) for piloting. METHODS AND ANALYSIS: A mixed-methods longitudinal pilot study will be conducted in 60 care homes (approximately 960 residents) in 3 regions of England, using resident data from cloud-based digital care home records at two-time points. These will be linked to resident and care home level data held within routine National Health Service and social care data sets. Two rounds of focus groups with care home staff (n=8-10 per region) and additional interviews with external stakeholders (n=3 per region) will explore implementation and the perceived utility of the MDS. Data will be assessed for completeness and timeliness of completion. Descriptive statistics, including percentage floor and ceiling effects, will establish data quality. For validated scales, construct validity will be assessed by hypothesis testing and exploratory factor analysis will establish structural validity. Internal consistency will be established using Cronbach's alpha. Longitudinal analysis of the pilot data will demonstrate the value of the MDS to each region. Qualitative data will be analysed inductively using thematic analysis to understand the complexities of implementing an MDS in care homes for older people. ETHICS AND DISSEMINATION: The study has received ethical approval from the London Queen's Square Research Ethics Committee (22/LO/0250). Informed consent is required for participation. Findings will be disseminated to: academics working on data use and integration in social care, care sector organisations, policy makers and commissioners. Findings will be published in peer-reviewed journals. Partner NIHR Applied Research Collaborations, the National Care Forum and the British Geriatrics Society will disseminate policy briefs.


Subject(s)
Research Design , State Medicine , Humans , Aged , Pilot Projects , England , London
7.
Int J Geriatr Psychiatry ; 38(1): e5868, 2023 01.
Article in English | MEDLINE | ID: mdl-36642866

ABSTRACT

OBJECTIVES: We culturally adapted STrAtegies for RelaTives (START), a clinically and cost-effective intervention for dementia family carers, for Black and South Asian families. It had previously been delivered to family carers around the time of diagnosis, when most people with dementia had very mild, mild or moderate dementia. METHODS: We interviewed a maximum variation sample of family carers (phase one; n = 15 South Asian; n = 11 Black) about what aspect of START, required cultural adaptation, then analysed it thematically using the Cultural Treatment Adaptation Framework then adapted it in English and into Urdu. Facilitators then delivered START individually to carers (phase two; n = 13 South Asian; n = 8 Black). We assessed acceptability and feasibility through the number of sessions attended, score for fidelity to the intervention and interviewing family carers about their experiences. We used the Hospital Anxiety and Depression Scale. to examine whether immediate changes in family carers' mental health were in line with previous studies. RESULTS: In phase one we made adaptations to peripheral elements of START, clarifying language, increasing illustrative vignettes numbers, emphasising privacy and the facilitator's cultural competence and making images ethnically diverse. In phase two 21 family carers consented to receive the adapted intervention; 12 completed ≥5/8 sessions; four completed fewer sessions and five never started. Baseline HADS score (n = 21) was 14.4 (SD = 9.8) but for those who we were able to follow up was 12.3 (SD 8.1) and immediately post-intervention was 11.3 (n = 10; SD = 6.1). Family carers were positive about the adapted START and continued to use elements after the intervention. CONCLUSIONS: Culturally adapted START was acceptable and feasible in South Asian and Black UK-based family carers and changes in mental health were in line with those in the original clinical trial. Our study shows that culturally inclusive START was also acceptable. Changes made in adaptations were relevant to all populations. We now use the adapted version for all family carers irrespective of ethnicity.


Subject(s)
Caregivers , Dementia , Humans , Asian People , Caregivers/psychology , Dementia/therapy , Mental Health , United Kingdom , Black People
8.
Ageing Res Rev ; 83: 101782, 2023 01.
Article in English | MEDLINE | ID: mdl-36356799

ABSTRACT

This study aimed to systematically review and meta-analyse the prevalence of sleep disturbances in people with dementia and examine demographic predictors and whether overall prevalence has changed over time. We searched Embase, MEDLINE and PsycINFO for studies reporting the prevalence of sleep disturbances in people with dementia living at home. We meta-analysed the data and calculated the pooled prevalence of sleep disturbances in people with dementia overall and in dementia subtypes. We used meta-regressions to investigate the effects of study characteristics, publication dates and participant demographics. Eleven studies fulfilled the inclusion criteria. The pooled prevalence of any symptoms of sleep disturbance was 26 % (95 % confidence intervals, CI: 23-30 %; n = 2719) and of clinically significant sleep disturbance 19 % (13-25 %; n = 2753). The pooled prevalence of sleep disturbance symptoms was significantly lower among people with Alzheimer's disease (24 %; 16-33 %, n = 310) than Lewy body dementia (49 %; 37-61 %, n = 65). Meta-regression analysis did not find that publication year, participant's age, sex and study quality predicted prevalence. Sleep disturbances are common among people with dementia living in the community, especially in Lewy body dementia. There was no change in prevalence according to publication dates, suggesting treatment has not improved over time.


Subject(s)
Dementia , Sleep Wake Disorders , Humans , Alzheimer Disease/epidemiology , Lewy Body Disease/epidemiology , Prevalence , Sleep Wake Disorders/epidemiology , Dementia/epidemiology , Male , Female , Independent Living
9.
Cogn Neuropsychiatry ; 27(6): 393-410, 2022 11.
Article in English | MEDLINE | ID: mdl-35975632

ABSTRACT

Introduction: Depression and anxiety symptoms are highly prevalent in schizophrenia-spectrum disorders and are commonly associated with schizotypy in non-clinical samples. However, it remains unclear what factors could be contributing to the relationships between schizotypy and anxiety and depression symptoms. Using path analysis, we explored the complex interplay between schizotypy, metacognitive beliefs, cognitive insight, and symptoms of emotional distress.Methods: Self-report data of schizotypy, metacognitive beliefs, cognitive insight, depression, and anxiety symptoms were collected from 344 participants from a predominantly student sample.Results: Path analysis confirmed unique associations between schizotypy dimensions, metacognitive beliefs, and cognitive insight. Furthermore, negative beliefs about worry mediated the link between the schizotypy dimensions, unusual experiences, cognitive disorganisation, and introvertive anhedonia and both depression and anxiety symptoms. Lack of cognitive confidence also mediated the relationship between cognitive disorganisation and depression symptoms. Finally, the cognitive insight subcomponent self-reflectiveness mediated the relationship between unusual experiences and cognitive disorganisation and anxiety.Conclusions: This study significantly furthers our understanding of the complex relationship between schizotypy, metacognitive processes, and emotional distress. Our findings also provide support for interventions which modify metacognitive beliefs and self-reflectiveness, which may prove beneficial for treatment in clinical settings.


Subject(s)
Metacognition , Schizotypal Personality Disorder , Anxiety/psychology , Anxiety Disorders , Depression/psychology , Humans , Schizotypal Personality Disorder/psychology
10.
PLoS One ; 17(8): e0272814, 2022.
Article in English | MEDLINE | ID: mdl-35944055

ABSTRACT

BACKGROUND: Sleep disturbances affect 38% of care home residents living with dementia. They are often treated with medication, but non-pharmacological interventions may be safer and effective yet more difficult to implement. In the SIESTA study (Sleep problems In dEmentia: interviews with care home STAff) we explored care home staffs' experience of managing sleep disturbances in their residents living with dementia. METHODS: We conducted one-to-one semi-structured interviews in four UK care homes, and purposively recruited a maximum variation sample of 18 nurses and care assistants, who were each interviewed once. We used a topic guide and audio-recorded the interviews. Two researchers independently analysed themes from transcribed interviews. RESULTS: Staff used a range of techniques that often worked in improving or preventing residents' sleep disturbance. During the daytime, staff encouraged residents to eat well, and be physically active and stimulated to limit daytime sleep. In the evening, staff settled residents into dark, quiet, comfortable bedrooms often after a snack. When residents woke at night, they gave them caffeinated tea or food, considered possible pain and discomfort, and reassured residents they were safe. If residents remained unsettled, staff would engage them in activities. They used telecare to monitor night-time risk. Staff found minimising daytime napping difficult, described insufficient staffing at night to attend to reorient and guide awake residents and said residents frequently did not know it was night-time. CONCLUSIONS: Some common techniques, such as caffeinated drinks, may be counterproductive. Future non-pharmacological interventions should consider practical difficulties staff face in managing sleep disturbances, including struggling to limit daytime napping, identifying residents' night-time needs, day-night disorientation, and insufficient night-time staffing.


Subject(s)
Dementia , Sleep Wake Disorders , Dementia/complications , Dementia/therapy , Humans , Nursing Homes , Qualitative Research , Sleep , Sleep Wake Disorders/etiology , Sleep Wake Disorders/therapy
11.
Alzheimers Dement (N Y) ; 8(1): e12251, 2022.
Article in English | MEDLINE | ID: mdl-35128034

ABSTRACT

INTRODUCTION: People living with dementia in care homes often have sleep disturbances, but little is known about incidence and importance. METHODS: We interviewed 1483 participants in 97 care homes and report prevalence, 1-year incidence, and baseline associations of clinically significant sleep disturbance in people with dementia. RESULTS: Baseline prevalence of clinically significant sleep disturbance was 13.7% (200/1460); 31.3% (457/1462) had them at least once over 16 months. One-year incidence was 25.2%. At baseline, residents with sleep disturbance had lower quality of life (mean difference -4.84; 95% confidence interval [CI] -6.53 to -3.16) and were more frequently prescribed sleep medications (odds ratio 1.75; CI 1.17 to 2.61) than other residents. DISCUSSION: Approximately one-third of care home residents with dementia have or develop sleep disturbances over 1 year. These are associated with lower quality of life and prescription of sedatives, which may have negative outcomes; therefore, it is important to develop effective treatments.

12.
Vet Pathol ; 59(2): 299-309, 2022 03.
Article in English | MEDLINE | ID: mdl-34872393

ABSTRACT

This study was designed to identify the cause of mutilation and death in 32 cats, part of a larger cohort found dead in Greater London, the United Kingdom, between 2016 and 2018. At the time, discussion in the media led to concerns of a human serial cat killer (dubbed The Croydon Cat Killer) pursuing domestic cats, causing a state of disquietude. Given the link between animal abuse and domestic violence, human intervention had to be ruled out. Using a combination of DNA testing, computed tomography imaging, and postmortem examination, no evidence was found to support any human involvement. Instead, a significant association between cat carcass mutilation and the presence of fox DNA was demonstrated. Gross examination identified shared characteristics including the pattern of mutilation, level of limb or vertebral disarticulation, wet fur, wound edges with shortened fur, and smooth or irregular contours, and marks in the skin, muscle, and bone consistent with damage from carnivore teeth. Together these findings supported the theory that the cause of mutilation was postmortem scavenging by red foxes (Vulpes vulpes). The probable cause of death was established in 26/32 (81%) carcasses: 10 were predated, 8 died from cardiorespiratory failure, 6 from blunt force trauma, one from ethylene glycol toxicity, and another from liver failure. In 6 carcasses a cause of death was not established due to autolysis and/or extensive mutilation. In summary, this study highlights the value of a multidisciplinary approach to fully investigate cases of suspected human-inflicted mutilation of animals.


Subject(s)
Carnivora , Foxes , Animals , Cats , Humans , United Kingdom
13.
Int Psychogeriatr ; 33(10): 1069-1081, 2021 10.
Article in English | MEDLINE | ID: mdl-32928327

ABSTRACT

OBJECTIVES: To develop a staff training intervention for agitation in people with severe dementia, reaching end-of-life, residing in nursing homes (NHs), test feasibility, acceptability, and whether a trial is warranted. DESIGN: Feasibility study with pre- and post-intervention data collection, qualitative interviews, and focus groups. SETTING: Three NHs in South East England with dementia units, diverse in terms of size, ownership status, and location. PARTICIPANTS: Residents with a dementia diagnosis or scoring ≥2 on the Noticeable Problems Checklist, rated as "severe" on Clinical Dementia Rating Scale, family carers, and staff (healthcare assistants and nurses). INTERVENTION: Manualized training, delivered by nonclinical psychology graduates focusing on agitation in severe dementia, underpinned by a palliative care framework. MEASUREMENTS: Main outcomes were feasibility of recruitment, data collection, follow-up, and intervention acceptability. We collected resident, family carer, and staff demographics. Staff provided data on resident's agitation, pain, quality of life, and service receipt. Staff reported their sense of competence in dementia care. Family carers reported on satisfaction with end-of-life care. In qualitative interviews, we explored staff and family carers' views on the intervention. RESULTS: The target three NHs participated: 28 (49%) residents, 53 (74%) staff, and 11 (85%) family carers who were eligible to participate consented. Eight-four percent of staff attended ≥3 sessions, and we achieved 93% follow-up. We were able to complete quantitative interviews. Staff and family carers reported the intervention and delivery were acceptable and helpful. CONCLUSIONS: The intervention was feasible and acceptable indicating a larger trial for effectiveness may be warranted.


Subject(s)
Dementia , Quality of Life , Death , Dementia/therapy , Feasibility Studies , Humans , Nursing Homes
14.
Int J Geriatr Psychiatry ; 35(11): 1418-1423, 2020 11.
Article in English | MEDLINE | ID: mdl-32725642

ABSTRACT

OBJECTIVES: Sleep disturbances in dementia causes distress to people with dementia and their family carers and are associated with care home admission. The Sleep Disorders Inventory (SDI) is a validated questionnaire of sleep disturbances in dementia often used to measure treatment effectiveness, but the minimum clinically important difference (MCID) is unknown. METHODS: We triangulated three investigative methods to determine the MCID of the SDI. Using data on SDI from a randomised controlled trial (RCT) with 62 participants in an intervention for sleep disorders in dementia, we (1) calculated distribution-based values where MCID = 0.33 of a SD (SD) (2) an anchor based approach using quality of life (measured using DEMQOL-Proxy) as an anchor. We also employed a Delphi consensus process asking 12 clinicians, sleep researchers and family carers to rate which changes on vignettes were equivalent to a MCID. RESULTS: We found that 0.33 SD in the SDI = 4.86. Reduction in SDI total score was not significantly correlated with improvement in DEMQOL-Proxy (Pearson's correlation = -0.01; P = 0.96) score. The Delphi consensus required two rounds to reach a consensus and concluded that changes equivalent to three points on the SDI equated to the MCID. CONCLUSIONS: Taking into account both the distribution-based values and the Delphi process we used a whole number at the midpoint and judged the minimum clinically important difference MCID to be equal to four points. We note the clinicians and carers opinions from the Delphi process determined the MCID to be lower at three points.


Subject(s)
Dementia , Sleep Wake Disorders , Caregivers , Humans , Quality of Life , Sleep Wake Disorders/diagnosis , Sleep Wake Disorders/etiology , Surveys and Questionnaires
15.
BMJ Open ; 10(7): e038430, 2020 07 07.
Article in English | MEDLINE | ID: mdl-32641367

ABSTRACT

INTRODUCTION: The BRIGhTMIND study aims to determine the clinical effectiveness, cost-effectiveness and mechanism of action of connectivity guided intermittent theta burst stimulation (cgiTBS) versus standard repetitive transcranial magnetic stimulation (rTMS) in adults with moderate to severe treatment resistant depression. METHODS AND ANALYSIS: The study is a randomised double-blind controlled trial with 1:1 allocation to either 20 sessions of (1) cgiTBS or (2) neuronavigated rTMS not using connectivity guidance. A total of 368 eligible participants with a diagnosis of current unipolar major depressive disorder that is both treatment resistant (defined as scoring 2 or more on the Massachusetts General Hospital Staging Score) and moderate to severe (scoring >16 on the 17-item Hamilton Depression Rating Scale (HDRS-17)), will be recruited from primary and secondary care settings at four treatment centres in the UK. The primary outcome is depression response at 16 weeks (50% or greater reduction in HDRS-17 score from baseline). Secondary outcomes include assessments of self-rated depression, anxiety, psychosocial functioning, cognition and quality of life at 8, 16 and 26 weeks postrandomisation. Cost-effectiveness, patient acceptability, safety, mechanism of action and predictors of response will also be examined. ETHICS AND DISSEMINATION: Ethical approval was granted by East Midlands Leicester Central Research Ethics Committee (ref: 18/EM/0232) on 30 August 2018. The results of the study will be published in relevant peer-reviewed journals, and then through professional and public conferences and media. Further publications will explore patient experience, moderators and mediators of outcome and mechanism of action. TRIAL REGISTRATION NUMBER: ISRCTN19674644.


Subject(s)
Depressive Disorder, Major , Depressive Disorder, Treatment-Resistant , Adult , Depression , Depressive Disorder, Major/therapy , Depressive Disorder, Treatment-Resistant/therapy , Double-Blind Method , Humans , Massachusetts , Quality of Life , Randomized Controlled Trials as Topic , Transcranial Magnetic Stimulation , Treatment Outcome
16.
Int Psychogeriatr ; 32(7): 839-847, 2020 07.
Article in English | MEDLINE | ID: mdl-32434617

ABSTRACT

OBJECTIVES: Nearly 40% of care home residents who are living with dementia also have symptoms of disturbed sleep. However, the impact of these disturbances is relatively unknown and is needed to indicate whether interventions are warranted; therefore, we aimed to investigate the impact. DESIGN: One-to-one semi-structured interviews. SETTINGS: Four UK care homes. PARTICIPANTS: We interviewed 18 nurses and care assistants about residents with sleep disturbances. MEASUREMENTS: We used a topic guide to explore staff experience of sleep disturbance in residents with dementia. The interviews were audio recorded and transcribed and then analyzed thematically by two researchers independently. RESULTS: Staff described that sleep disturbances in most, but not all, residents impacted negatively on the resident, other residents, staff, and relatives. Residents became more irritable or agitated if they had slept badly. They slept in the daytime after a bad night, which then increased their chances of being awake the following night. For some, being sleepy in the day led to falls, missing medication, drinks, and meals. Staff perceived hypnotics as having low efficacy, but increasing the risk of falls and drowsiness. Other residents were disturbed by noise, and staff described stress when several residents had sleep disturbance. Some of the strategies reported by staff to deal with sleep disturbances such as feeding or providing caffeinated tea at night might be counterproductive. CONCLUSIONS: Sleep disturbances in care home residents living with dementia negatively affect their physical and psychological well-being. These disturbances also disturb other residents and increase stress in staff.


Subject(s)
Caregivers/psychology , Dementia/psychology , Health Personnel , Sleep Wake Disorders/psychology , Adult , Homes for the Aged , Humans , Interviews as Topic , Male , Middle Aged , Nursing Homes , Qualitative Research , Sleep/physiology , Sleep Wake Disorders/physiopathology , Wakefulness/physiology
17.
Sleep ; 43(4)2020 04 15.
Article in English | MEDLINE | ID: mdl-31633188

ABSTRACT

STUDY OBJECTIVES: Sleep disturbances are a feature in people living with dementia, including getting up during the night, difficulty falling asleep, and excessive daytime sleepiness and may precipitate a person with dementia moving into residential care. There are varying estimates of the frequency of sleep disturbances, and it is unknown whether they are a problem for the individual. We conducted the first systematic review and meta-analysis on the prevalence and associated factors of sleep disturbances in the care home population with dementia. METHODS: We searched Embase, MEDLINE, and PsycINFO (29/04/2019) for studies of the prevalence or associated factors of sleep disturbances in people with dementia living in care homes. We computed meta-analytical estimates of the prevalence of sleep disturbances and used meta-regression to investigate the effects of measurement methods, demographics, and study characteristics. RESULTS: We included 55 studies of 22,780 participants. The pooled prevalence on validated questionnaires of clinically significant sleep disturbances was 20% (95% confidence interval, CI 16% to 24%) and of any symptom of sleep disturbance was 38% (95% CI 33% to 44%). On actigraphy using a cutoff sleep efficiency of <85% prevalence was 70% (95% CI 55% to 85%). Staff distress, resident agitation, and prescription of psychotropic medications were associated with sleep disturbances. Studies with a higher percentage of males had a higher prevalence of sleep disturbance. CONCLUSIONS: Clinically significant sleep disturbances are less common than those measured on actigraphy and are associated with residents and staff distress and the increased prescription of psychotropics. Actigraphy appears to offer no benefit over proxy reports in this population.


Subject(s)
Dementia , Sleep Initiation and Maintenance Disorders , Sleep Wake Disorders , Dementia/epidemiology , Humans , Male , Prevalence , Sleep , Sleep Wake Disorders/epidemiology
18.
Curr Biol ; 29(6): R198-R199, 2019 03 18.
Article in English | MEDLINE | ID: mdl-30889387

ABSTRACT

Seafood is one of the most traded food commodities in the world with demand steadily increasing [1]. There is, however, a rising concern over the vulnerability of seafood supply chains to species mislabelling and fraud [1,2]. DNA methods have been widely used to detect species mislabelling and a recent meta-analysis of 4500 seafood product tests from 51 publications found an average of 30 percent were not the species stated on the label or menu [3]. This high rate poses a serious threat to consumer trust, reputations of seafood businesses and the sustainability of fishery resources. Seafood certification schemes may help reduce this problem. Here, we use DNA barcoding [4] to validate the species identity of 1402 certified seafood products derived from 27 species across 18 countries and find that in over 99% of cases species labelling was correct.


Subject(s)
DNA Barcoding, Taxonomic/statistics & numerical data , Seafood/classification , Food Handling , Food-Processing Industry
19.
Int Psychogeriatr ; 31(2): 251-265, 2019 02.
Article in English | MEDLINE | ID: mdl-30221615

ABSTRACT

ABSTRACTBackground:40% of people with dementia have disturbed sleep but there are currently no known effective treatments. Studies of sleep hygiene and light therapy have not been powered to indicate feasibility and acceptability and have shown 40-50% retention. We tested the feasibility and acceptability of a six-session manualized evidence-based non-pharmacological therapy; Dementia RElAted Manual for Sleep; STrAtegies for RelaTives (DREAMS-START) for sleep disturbance in people with dementia. METHODS: We conducted a parallel, two-armed, single-blind randomized trial and randomized 2:1 to intervention: Treatment as Usual. Eligible participants had dementia and sleep disturbances (scoring ≥4 on one Sleep Disorders Inventory item) and a family carer and were recruited from two London memory services and Join Dementia Research. Participants wore an actiwatch for two weeks pre-randomization. Trained, clinically supervised psychology graduates delivered DREAMS-START to carers randomized to intervention; covering Understanding sleep and dementia; Making a plan (incorporating actiwatch information, light exposure using a light box); Daytime activity and routine; Difficult night-time behaviors; Taking care of your own (carer's) sleep; and What works? Strategies for the future. Carers kept their manual, light box, and relaxation recordings post-intervention. Outcome assessment was masked to allocation. The co-primary outcomes were feasibility (≥50% eligible people consenting to the study) and acceptability (≥75% of intervention group attending ≥4 intervention sessions). RESULTS: In total, 63out of 95 (66%; 95% CI: 56-76%) eligible referrals consented between 04/08/2016 and 24/03/2017; 62 (65%; 95% CI: 55-75%) were randomized, and 37 out of 42 (88%; 95% CI: 75-96%) adhered to the intervention. CONCLUSIONS: DREAM-START for sleep disorders in dementia is feasible and acceptable.


Subject(s)
Caregivers , Dementia/complications , Sleep Wake Disorders/therapy , Aged , Aged, 80 and over , Cognitive Behavioral Therapy , Cost-Benefit Analysis , Exercise , Feasibility Studies , Female , Humans , Male , Single-Blind Method , Surveys and Questionnaires , Treatment Outcome , United Kingdom
20.
Health Technol Assess ; 22(71): 1-408, 2018 12.
Article in English | MEDLINE | ID: mdl-30538021

ABSTRACT

BACKGROUND: It has been estimated that between 25% and 40% of people living with dementia suffer from sleep disturbances, and there are currently no known effective treatments. Sleep disturbances may be the direct result of dementia or due to other comorbidities, such as pain and limited mobility. If carers' sleep is also disturbed, carers too can become tired and stressed, and this sometimes results in the breakdown of care in the home. OBJECTIVES: To design an evidence-based manualised non-pharmacological therapy for sleep disturbances and test it for feasibility and acceptability. DESIGN: A single-blind, randomised, parallel-group feasibility trial, with participants randomised 2 : 1 to intervention or treatment as usual (TAU). SETTING: Five memory services in two London NHS trusts and Join Dementia Research (JDR). PARTICIPANTS: The study recruited people with dementia and sleep disturbances (who scored ≥ 4 on at least one question on the Sleep Disorders Inventory) and their primary family carers. INTERVENTION: All participants were given an Actiwatch (CamNtech Ltd, Cambridge, UK) to wear to record their sleep patterns for 2 weeks before randomisation. The intervention group received Dementia RElAted Manual for Sleep; STrAtegies for RelaTives (DREAMS START). This was designed as a six-session, manual-based intervention for carers of people with dementia, delivered by trained and clinically supervised psychology graduates, based on evidence about managing sleep disturbance in people with dementia. It uses the structure of a previous manual-based treatment, STrAtegies for RelaTives (START). Family carers were consulted about structure, content and design. Sessions were interactive, and each involved techniques, tasks to practise between sessions, relaxation and a recapitulation on the previous session. The sessions covered understanding sleep and dementia, making a plan (incorporating information from Actiwatch read-outs and a light box to increase light), daytime activity and routine, difficult night-time behaviours, taking care of your own (carer's) sleep and using the strategies in the future. Carers kept their own manual, light box and relaxation recordings post intervention. RANDOMISATION AND BLINDING: A statistician created an electronic randomisation list, stratified by site, using random permuted blocks. Those assessing the outcome were blinded to allocation; participants were not blinded. MAIN OUTCOME MEASURES: Outcomes were assessed at 3 months. (1) Feasibility, defined as the percentage of eligible people who consented to the study recruitment, with an expected value of 50% [95% confidence interval (CI) 41% to 59%]. (2) Acceptability, defined as the percentage of intervention group participants attending ≥ 4 intervention sessions, with an expected value of 75% (95% CI 59% to 87%). The predetermined criterion for progression to the main trial was acceptability of ≥ 70%. RESULTS: Of 95 eligible patients referred, 63 (66%, 95% CI 56% to 76%) consented between 4 August 2016 and 24 March 2017: 61 from memory clinics and two from JDR. Of these, 62 participants (65%, 95% CI 55% to 75%) were randomised: 42 to the intervention arm and 20 to the TAU arm. Thirty-seven out of 42 participants (88%, 95% CI 75% to 96%) adhered to the intervention. CONCLUSIONS: The results show that the randomised controlled trial is feasible and that the intervention is acceptable. A higher than expected proportion of eligible patients referred consented to the study and adhered to the intervention. LIMITATIONS: Participants were not blinded and were recruited only in London. FUTURE WORK: The results of this trial indicate that a future efficacy trial is warranted. TRIAL REGISTRATION: Current Controlled Trials ISCTRN36983298. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 71. See the NIHR Journals Library website for further project information. Funding was also provided by Camden and Islington NHS Foundation Trust and Barnet, Enfield and Haringey Mental Health NHS Trust to pay for excess treatment costs from therapist training and supervision and intervention delivery.


Subject(s)
Caregivers/psychology , Dementia/therapy , Sleep Wake Disorders/therapy , Treatment Outcome , Actigraphy/methods , Aged , Aged, 80 and over , Cost-Benefit Analysis , Female , Humans , London , Male , Middle Aged , Single-Blind Method , Surveys and Questionnaires , Technology Assessment, Biomedical
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