Community based complex interventions to sustain independence in older people: systematic review and network meta-analysis.

OBJECTIVE: To synthesise evidence of the effectiveness of community based complex interventions, grouped according to their intervention components, to sustain independence for older people. DESIGN: Systematic review and network meta-analysis. DATA SOURCES: Medline, Embase, CINAHL, PsycINFO, CENTRAL, clinicaltrials.gov, and International Clinical Trials Registry Platform from inception to 9 August 2021 and reference lists of included studies. ELIGIBILITY CRITERIA: Randomised controlled trials or cluster randomised controlled trials with ≥24 weeks' follow-up studying community based complex interventions for sustaining independence in older people (mean age ≥65 years) living at home, with usual care, placebo, or another complex intervention as comparators. MAIN OUTCOMES: Living at home, activities of daily living (personal/instrumental), care home placement, and service/economic outcomes at 12 months. DATA SYNTHESIS: Interventions were grouped according to a specifically developed typology. Random effects network meta-analysis estimated comparative effects; Cochrane's revised tool (RoB 2) structured risk of bias assessment. Grading of recommendations assessment, development and evaluation (GRADE) network meta-analysis structured certainty assessment. RESULTS: The review included 129 studies (74 946 participants). Nineteen intervention components, including "multifactorial action from individualised care planning" (a process of multidomain assessment and management leading to tailored actions), were identified in 63 combinations. For living at home, compared with no intervention/placebo, evidence favoured multifactorial action from individualised care planning including medication review and regular follow-ups (routine review) (odds ratio 1.22, 95% confidence interval 0.93 to 1.59; moderate certainty); multifactorial action from individualised care planning including medication review without regular follow-ups (2.55, 0.61 to 10.60; low certainty); combined cognitive training, medication review, nutritional support, and exercise (1.93, 0.79 to 4.77; low certainty); and combined activities of daily living training, nutritional support, and exercise (1.79, 0.67 to 4.76; low certainty). Risk screening or the addition of education and self-management strategies to multifactorial action from individualised care planning and routine review with medication review may reduce odds of living at home. For instrumental activities of daily living, evidence favoured multifactorial action from individualised care planning and routine review with medication review (standardised mean difference 0.11, 95% confidence interval 0.00 to 0.21; moderate certainty). Two interventions may reduce instrumental activities of daily living: combined activities of daily living training, aids, and exercise; and combined activities of daily living training, aids, education, exercise, and multifactorial action from individualised care planning and routine review with medication review and self-management strategies. For personal activities of daily living, evidence favoured combined exercise, multifactorial action from individualised care planning, and routine review with medication review and self-management strategies (0.16, -0.51 to 0.82; low certainty). For homecare recipients, evidence favoured addition of multifactorial action from individualised care planning and routine review with medication review (0.60, 0.32 to 0.88; low certainty). High risk of bias and imprecise estimates meant that most evidence was low or very low certainty. Few studies contributed to each comparison, impeding evaluation of inconsistency and frailty. CONCLUSIONS: The intervention most likely to sustain independence is individualised care planning including medicines optimisation and regular follow-up reviews resulting in multifactorial action. Homecare recipients may particularly benefit from this intervention. Unexpectedly, some combinations may reduce independence. Further research is needed to investigate which combinations of interventions work best for different participants and contexts. REGISTRATION: PROSPERO CRD42019162195.

What are the priorities for research of older people living in their own home, including those living with frailty? A systematic review and content analysis of studies reporting older people's priorities and unmet needs.

BACKGROUND: There is limited evidence regarding the needs of older people, including those living with frailty, to inform research priority setting. OBJECTIVES: This systematic review aimed to identify the range of research priorities of community-dwelling older people living in their own home, including those living with frailty. METHODS: Included studies were from economically developed countries and designed to identify the priorities for research or unmet needs of community-dwelling older people. Studies were excluded if they described priorities relating to specific health conditions. Medline, Embase, PsycInfo and CINAHL were searched (January 2010-June 2022), alongside grey literature. Study quality was assessed, but studies were not excluded on the basis of quality. A bespoke data extraction form was used and content analysis undertaken to synthesise findings. RESULTS: Seventy-five reports were included. Seven explicitly aimed to identify the priorities or unmet needs of frail older people; 68 did not specify frailty as a characteristic. Study designs varied, including priority setting exercises, surveys, interviews, focus groups and literature reviews. Identified priorities and unmet needs were organised into themes: prevention and management, improving health and care service provision, improving daily life, meeting carers' needs and planning ahead. DISCUSSION: Many priority areas were raised by older people, carers and health/care professionals, but few were identified explicitly by/for frail older people. An overarching need was identified for tailored, collaborative provision of care and support. CONCLUSION: Review findings provide a valuable resource for researchers and health/care staff wishing to focus their research or service provision on areas of importance for older people.

Risk-of-bias assessment using Cochrane's revised tool for randomized trials (RoB 2) was useful but challenging and resource-intensive: observations from a systematic review.

OBJECTIVES: To report our experience using version 2 of the Cochrane risk-of-bias tool for randomized trials (RoB 2). STUDY DESIGN AND SETTING: Two reviewers independently applied RoB 2 to results of interest in a large systematic review of complex interventions and reached consensus. We recorded the time taken, and noted and discussed our difficulties using the tool, and the resolutions we adopted. We explored the time taken with regression analysis and summarized our experience of implementing the tool. RESULTS: We assessed risk of bias in 860 results of interest in 113 studies. Staff resource averaged 358 minutes per study (SD 183). Number of results (ß = 22) and reports (ß = 14) per study and experience of the team (ß = -6) significantly affected assessment time. To implement the tool consistently, we developed cut points for missingness and considerations of balance regarding missingness, assumed some concerns with intervention deviations unless otherwise prevented or investigated, some concerns with measurements from unblinded self-reporting participants, and judged low risk of selection for certain dichotomous outcomes despite the absence of an analysis plan. CONCLUSION: The RoB 2 tool and guidance are useful but resource-intensive and challenging to implement. Critical appraisal tools and reporting guidelines should detail risk of bias implementation. Improved guidance focusing on implementation could assist reviewers.

Eligibility screening older research participants using remote cognitive assessment-experiences and reflections from a primary care randomised controlled trial.

BACKGROUND: The COVID-19 pandemic forced many research teams to adjust the way they conduct studies, including moving to remote delivery of some or all of their recruitment and data collection processes. The Montreal Cognitive Assessment (MoCA) is widely used in research and is available in multiple formats for different groups and assessment settings. Here, we reflect on our experiences of administering the MoCA Blind/Telephone as part of the initial telephone eligibility check for participation in a randomised controlled trial with community-dwelling older people with frailty. MAIN BODY: In response to COVID-19, a number of changes were made to the trial's screening and recruitment procedures, to minimise the amount of time the researchers would spend in the participants' homes when recruitment began in May 2021. One of the changes was for the researchers to conduct a cognitive assessment for eligibility during an initial telephone call, rather than during the subsequent home visit for consent and baseline data collection. We found that in comparison with conducting the assessment in-person, telephone administration caused uncertainty for the researchers about whether participants were struggling to answer questions due to cognition or hearing impairment. Some participants experienced practical difficulties when combining holding a telephone and completing one of the assessment items. It was hard for the researchers to judge the emotional impact that undertaking the assessment was having on the older people on the telephone, without visual warning signs of fatigue or mood. We discuss the potential impact of these issues on trial recruitment and participant engagement, and the feasibility of videoconferencing as an alternative method of conducting the MoCA. CONCLUSION: The MoCA is a useful tool when cognitive impairment is part of screening and data collection and it is helpful to have the option to use the test remotely. However, as we have found, telephone testing is not always straightforward. Researchers should weigh up the pros and cons for each individual study, especially those involving older adults. If choosing remote methods, consider the practicality of using videoconferencing and think about the possible impact of telephone assessment on the relationship with the (potential) research participants. TRIAL REGISTRATION: Personalised care planning for older people with frailty ISRCTN16123291 28/08/2020.

Community Ageing Research 75+ (CARE75+) REMOTE study: a remote model of recruitment and assessment of the health, well-being and social circumstances of older people.

INTRODUCTION: The Community Ageing Research 75+ (CARE75+) study is a longitudinal cohort study collecting extensive health and social data, with a focus on frailty, independence and quality of life in older age. CARE75+ was the first international experimental frailty research cohort designed using trial within cohorts (TwiCs) methodology, aligning epidemiological research with clinical trial evaluation of interventions to improve the health and well-being of older people. CARE75+ REMOTE is an extension of CARE75+ using a remote model that does not require face-to-face interactions for data collection in the current circumstances of a global pandemic and will provide an efficient, sustainable data collection model. METHODS AND ANALYSIS: Prospective cohort study using TwiCs. One thousand community-dwelling older people (≥75 years) will be recruited from UK general practices by telephone. Exclusions include: nursing home/care home residents; those with an estimated life expectancy of 3 months or less; and people receiving palliative care. DATA COLLECTION: Assessments will be conducted by telephone, web-submission or postal questionnaire: baseline, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months. Measures include activities of daily living, mood, health-related quality of life, comorbidities, medications, frailty, informal care, healthcare and social care service use. Consent will be sought for data linkage and invitations to additional studies (sub-studies). ETHICS AND DISSEMINATION: CARE75+ was approved by the National Research Ethics Service (NRES) Committee Yorkshire and the Humber-Bradford Leeds 10 October 2014 (14/YH/1120). CARE75+ REMOTE (amendment 13) was approved on the 18th November 2020. Consent is sought if an individual is willing to participate and has capacity to provide informed consent. Consultee assent is sought if an individual lacks capacity. Results will be disseminated in peer-reviewed scientific journals and conferences. Results will be summarised and disseminated to study participants via newsletters, local engagement events and on a bespoke website. TRIAL REGISTRATION NUMBER: ISRCTN16588124.

The cost of community research-recruiting community-dwelling participants to a feasibility primary care cluster randomised controlled trial.

BACKGROUND: To support a robust evidence base for the organisation and provision of community-delivered health services for older people, clinical trials need to be designed to account for community-based participant recruitment. There is currently little reported information available on the time and cost of recruiting community-dwelling older people, which makes the completion of cost attribution documentation problematic when applying for research funding. MAIN BODY: We aimed to establish the amount of researcher time it takes to recruit community-dwelling older people to a feasibility primary care cluster randomised controlled trial, including collecting baseline data. The trial was part of a programme of work investigating an intervention to improve the quality of life for older people with frailty. Two researchers conducting home visits to recruit and collect baseline data from participants recorded the time spent on travelling to and from the visit, at the visit itself and any associated administration. The median total researcher activity time per visit was 148 min. We discuss the various elements of recruitment and data collection activity and the factors that impacted the length of time taken, including location, individuals' capacity and cognition, hearing and visual impairment and the desire for social contact. CONCLUSION: Studies cannot reach their recruitment targets if they are unrealistically planned and resourced. We recommend that trials recruiting older people in the community allocate two and a half hours of researcher time per person, on average, for consent, baseline data collection, travel and administration. We acknowledge that a variety of different factors will mean that researcher activity will vary between different community-based trials. Our findings give a good starting point for timing calculations, and evidence on which to base the justification of research activity costings. TRIAL REGISTRATION: Personalised care planning for older people with frailty ISRCTN12363970 . 08/11/2018.

Life in lockdown: a telephone survey to investigate the impact of COVID-19 lockdown measures on the lives of older people (≥75 years).

BACKGROUND: In response to the coronavirus disease 2019 (COVID-19) pandemic, the UK government introduced social distancing measures and identified specific populations at high risk from the virus. People ≥70 were deemed 'Clinically Vulnerable'. Distancing measures were introduced to reduce the risk of contracting COVID-19. However, these may have a negative impact on older people who are vulnerable to social isolation and may have challenges accessing services and provisions. OBJECTIVES: To investigate the impact of COVID-19 lockdown measures on the lives of older people. STUDY DESIGN AND SETTING: Cross-sectional telephone survey. PARTICIPANTS: Community-dwelling older people, 76-97 years. OUTCOMES: Health anxiety; General health (RAND Short-form 36 Survey); Physical activity; Depression (PHQ-8); Anxiety (GAD-2); Loneliness; Access to services; Challenges, concerns and positive experiences. DATA ANALYSIS: Counts (%), means (SDs). Thematic analysis was used to identify themes from open questions. RESULTS: n = 142. 52% did not worry about their health; 76% rated their health as 'good', 'very good' or 'excellent'; <10% met the criteria indicative of depression (PHQ-8), or anxiety (GAD-2); 42% were less active than before lockdown; and 27% were lonely at least some of the time. Over half of participants identified positive aspects. CONCLUSIONS: Most participants reported good health with low levels of health anxiety, anxiety and depression. Many were able to identify positive aspects to lockdown and may be better equipped to deal with lockdown than anticipated. Strategies may be required to ameliorate the negative impact of loneliness for a minority of older people, and help some resume previous activity levels and pursuits.

A cross-sectional study assessing agreement between self-reported and general practice-recorded health conditions among community dwelling older adults.

BACKGROUND: self-reported data regarding health conditions are utilised in both clinical practice and research, but their agreement with general practice records is variable. The extent of this variability is poorly studied amongst older adults, particularly amongst those with multiple health conditions, cognitive impairment or frailty. This study investigates the agreement between self-reported and general practice-recorded data amongst such patients and the impact of participant factors on this agreement. METHODS: data on health conditions was collected from participants in the Community Ageing Research 75+ (CARE75+) study (n = 964) by self-report during face-to-face assessment and interrogation of the participants' general practice electronic health records. Agreement between self-report and practice records was assessed using Kappa statistics and the effect of participant demographics using logistic regression. RESULTS: agreement ranged from K = 0.25 to 1.00. The presence of ≥2 health conditions modified agreement for cancer (odds ratio, OR:0.62, 95%confidence interval, CI:0.42-0.94), diabetes (OR:0.55, 95%CI:0.38-0.80), dementia (OR:2.82, 95%CI:1.31-6.13) and visual impairment (OR:3.85, 95%CI:1.71-8.62). Frailty reduced agreement for cerebrovascular disease (OR:0.45, 95%CI:0.23-0.89), heart failure (OR:0.40, 95%CI:0.19-0.84) and rheumatoid arthritis (OR:0.41, 95%CI:0.23-0.75). Cognitive impairment reduced agreement for dementia (OR:0.36, 95%CI:0.21-0.62), diabetes (OR:0.47, 95%CI:0.33-0.67), heart failure (OR:0.53, 95%CI:0.35-0.80), visual impairment (OR:0.42, 95%CI:0.25-0.69) and rheumatoid arthritis (OR:0.53, 95%CI:0.37-0.76). CONCLUSIONS: significant variability exists for agreement between self-reported and general practice-recorded comorbidities. This is further affected by an individual's health conditions. This study is the first to assess frailty as a factor modifying agreement and highlights the importance of utilising the general practice records as the gold standard for data collection from older adults.

Community ageing research 75+ study (CARE75+): an experimental ageing and frailty research cohort.

INTRODUCTION: The Community Ageing Research 75+ Study (CARE75+) is a longitudinal cohort study collecting an extensive range of health, social and economic data, with a focus on frailty, independence and quality of life in older age. CARE75+ is the first international experimental frailty research cohort designed using Trial within Cohorts (TwiCs) methodology, to align applied epidemiological research with clinical trial evaluation of interventions to improve the health and well-being of older people living with frailty. METHODS AND ANALYSIS: Prospective cohort study using a TwiCs design. One thousand community-dwelling older people (≥75 years) will be recruited from UK general practices. Nursing home residents, those with an estimated life expectancy of 3 months or less and people receiving palliative care will be excluded. Data collection assessments will be face to face in the person's home at baseline, 6 months, 12 months, 24 months and 48 months, including assessments of frailty, cognition, mood, health-related quality of life, comorbidity, medications, resilience, loneliness, pain and self-efficacy. A modified protocol for follow-up by telephone or web based will be offered at 6 months. Consent will be sought for data linkage and invitations to additional studies, including intervention studies using the TwiCs design. A blood sample biobank will be established for future basic science studies. ETHICS AND DISSEMINATION: CARE75+ was approved by the NRES Committee Yorkshire and the Humber-Bradford Leeds 10 October 2014 (14/YH/1120). Formal written consent is sought if an individual is willing to participate and has capacity to provide informed consent. Consultee assent is sought if an individual lacks capacity.Study results will be disseminated in peer-reviewed scientific journals and scientific conferences. Key study results will be summarised and disseminated to all study participants via newsletters, local older people's publications and local engagement events. Results will be reported on a bespoke CARE75+ website. TRIAL REGISTRATION NUMBER: ISRCTN16588124;Results stage.

Convergent validity of the electronic frailty index.

Background: the electronic frailty index (eFI) has been developed and validated using routine primary care electronic health record data. The focus of the original big data study was on predictive validity as a form of criterion validation. Convergent validity is a subtype of construct validity and considered a core component of the validity of a test. Objective: to investigate convergent validity between the eFI and research standard frailty measures. Design: cross-sectional validation study using data from the Community Ageing Research 75+ (CARE 75+) cohort. Setting: multi-site UK community-based cohort study. Subjects: three hundred fifty-three community-dwelling older people (median age 80 years, IQR 77-84), excluding care home residents and people in the terminal stage of life. Median eFI score of participants was 0.22 (IQR 0.14-0.31). Methods: convergent validities between the eFI and: a research standard frailty index (FI); the phenotype model of frailty; Clinical Frailty Scale (CFS) and Edmonton Frail Scale were assessed using scatter plots and Spearman's rank tests to estimate correlation coefficients (Spearman's rho, ρ) and 95% confidence intervals. Results: results indicate strong correlation between the eFI and both the research standard FI (ρ = 0.68, 95% CI 0.62-0.74) and Edmonton Frail Scale (ρ = 0.63, 95% CI 0.57-0.69). There was evidence for moderate correlation between the eFI and both the CFS (ρ = 0.59, 95% CI 0.49-0.65) and phenotype model (ρ = 0.51, 95% CI 0.42-0.59). Conclusions: This study provides evidence for convergent validity of the eFI, a core component of test validity.

A feasibility study to prevent falls in older people who are sight impaired: the VIP2UK randomised controlled trial.

BACKGROUND: Published evaluations of successful interventions to prevent falls in people with sight impairment (SI) are limited. The aim of this feasibility study is to optimise the design and investigation of home safety (HS) and home exercise (HE) programmes to prevent falls in older people with SI. METHODS: A community-based feasibility study in north-west England comprising a three-arm randomised controlled trial (RCT) allocated participants to (1) a control group receiving usual care and social visits, (2) an experimental group receiving the HS programme and (3) an experimental group receiving the HS + HE programme. Participants were community-dwelling, aged 65 years and older and sight impaired. Primary outcome data on falls were collected continuously over 6 months. Secondary outcomes on physical activity (self-report and instrumented) and adherence were collected at baseline and 3 and 6 months for HE and at 6 months for the HS programme. Costs for the HS and HS + HE groups were calculated from logs of time spent on home visits, telephone calls and travel. The research assistant and statistician were blinded to group allocation. RESULTS: Altogether, 49 people were recruited over a 9-month period (randomised: 16 to control, 16 to HS, 17 to HS + HE). The interventions were implemented over 6 months by an occupational therapist at a cost per person (pounds sterling, 2011) of £249 (HS) and £674 (HS + HE). Eighty-eight percent (43/49) completed the trial and 6-month follow-up. At 6-month follow-up, 100 % reported partially or completely adhering to HS recommendations but evidence for adherence to HE was equivocal. Although self-reported physical activity increased, instrumented monitoring showed a decrease in walking activity. There were no statistically significant differences in falls between the groups; however, the study was not powered to detect a difference. CONCLUSION: It is feasible and acceptable for an occupational therapist to deliver HS and HE falls prevention programmes to people with SI living independently in the community. Future studies could access Local Authority Registers of people with SI to improve recruitment rates. Further research is required to identify how to improve adherence to HE and to measure changes in physical activity before conducting a definitive RCT. TRIAL REGISTRATION: ISRCTN53433311 , registered on 8 May 2014.

The causes of falls: views of older people with visual impairment.

BACKGROUND: Sight impairment increases with age and, compared with the general older population, older people with sight impairment are more likely to fall. There is a growing body of evidence on the views and perceptions of older people about falls, but little is published on the views of older people with sight impairment. OBJECTIVE: To explore what older people with sight impairment believe to be the causes of falls. DESIGN: A qualitative design was used, incorporating focus groups and interviews in which participants discussed falls and falls prevention. Framework analysis was employed to identify themes arising from participants' discussions of the causes of falls. SETTING AND PARTICIPANTS: Fifty-four community dwelling men and women with sight impairment, aged 65 and over, were recruited from across Greater Manchester, UK. RESULTS: Five types of factors were identified that were believed to cause falls: (i) health issues and changes in balance caused by ageing; (ii) cognitive and behavioural factors; (iii) the impact of sight impairment on getting around the home; (iv) the impact of sight impairment on negotiating the environment away from home; and (v) unexplained falls. DISCUSSION AND CONCLUSIONS: Older people with sight impairment reported many researched risk factors previously identified by older people without sight impairment but also described many perceived risks unique to people with sight impairment. There are few interventions to prevent falls aimed at older people with sight impairment, and the results of this study allow further tailoring of such interventions based on views of older people with sight impairment.

Predicting cancer patients' participation in support groups: a longitudinal study.

OBJECTIVE: Few patients participate in cancer support groups despite their benefits. This study investigated the importance of Theory of Planned Behaviour variables in predicting group participation, relative to disease impact, existing support, coping and demographic variables. METHODS: Longitudinal study of patients with colorectal, lung or prostate cancer recruited from a specialist oncology centre. Patients self-completed surveys at baseline and six-month follow up. Baseline measures included Theory of Planned Behaviour (TPB) variables, distress and control over cancer (IPQ-R), coping (Brief COPE), social support (MSPSS), health related quality of life (EORTC QLQ-C30) and readiness to participate (PAPM). Group participation and recommendations to participate were measured at follow up. Univariable and Random Forest analyses investigated predictors of baseline readiness to participate and participation by six-month follow up. RESULTS: N=192 patients completed baseline questionnaires. N=13 participated in a group and N=59 did not by six-month follow up. Baseline readiness to participate was associated with inadequate support and positive views of support groups. Lower cognitive functioning, recommendations and readiness to participate predicted group participation by six-month follow up. CONCLUSION AND PRACTICE IMPLICATIONS: Practitioners may facilitate group participation by promoting positive views of groups, recommending participation and focusing on patients experiencing greater disease impact and less existing support.

The Carer Support Needs Assessment Tool (CSNAT) for use in palliative and end-of-life care at home: a validation study.

CONTEXT: Family carers need to be supported in their central role of caring for patients at the end of life, but brief practical tools to assess their support needs have been missing. To address this gap, we developed a brief evidence-based Carer Support Needs Assessment Tool (CSNAT) suitable for everyday practice. OBJECTIVES: To assess face, content, and criterion validity of the CSNAT and measure sensitivity to change over time. METHODS: Participants were 225 adult carers of patients from six U.K. Hospice Home Care services. Carers were surveyed at baseline and at four-week follow-up using self-completed questionnaires, including CSNAT, standard measures (distress, strain, positive appraisals, preparedness, and global health), help provided with activities of daily living, and patients' symptom levels. Qualitative feedback on CSNAT was sought through 10 pilot carer interviews and professional and carer advisory group input. RESULTS: The CSNAT has good face, content, and criterion validity. CSNAT domains comprehensively covered carer support needs. CSNAT scores showed clear and consistent positive correlations with strain and distress and negative correlations with preparedness for caregiving and global health. There also were clear correlations with help with activities of daily living and some relationships with positive appraisals and symptom burden. The CSNAT's sensitivity to change in relevant domains was similar to other measures. CONCLUSION: The CSNAT is a valid tool for the direct measurement of carers' support needs. It combines comprehensiveness of content with feasibility of administration and has utility both as a research tool and a tool for everyday palliative care practice.