Clinical and cost-effectiveness of 'Live Well with Parkinson's' self-management intervention versus treatment as usual for improving quality of life for people with Parkinson's: study protocol for a randomised controlled trial.

BACKGROUND: The Live Well with Parkinson's Self-Management Toolkit is designed for use in the NHS to support people with Parkinson's, their carers and health professionals in managing motor and non-motor symptoms and promoting well-being. The Toolkit was developed based on theory-based behaviour change and self-management techniques in consultation with people living with Parkinson's and health and social care practitioners. There are digital (e-Toolkit) and paper (manual) versions. METHODS: Single-blind two-arm randomised controlled trial RCT of clinical effectiveness and cost-effectiveness of the Toolkit, facilitated by up to six sessions with a trained non-specialist supporter, in improving quality of life. People with Parkinson's will be assessed at baseline, 6 and 12 months. Assessors will be blind to the treatment group. The primary outcome measure is the Parkinson's Disease Questionnaire (PDQ-39, Parkinson's related quality of life) score at 12 months. Secondary outcome measures include the MDS Unified Parkinson's Disease Rating Scale (Part I, II, III, IV), EQ-5D, and a Client Service Receipt Inventory shortened, adapted for Parkinson's. Carer outcomes include the Zarit Carer Burden Inventory and Carer Quality of Life Questionnaire for Parkinsonism. A total of 338 people with Parkinson's, and their carers if appropriate, will be recruited from diverse settings across England. Those with advanced dementia, at end-of-life or with atypical Parkinsonism will be excluded. A parallel mixed methods process evaluation will explore the factors promoting or inhibiting implementation, uptake, use, effectiveness and cost-effectiveness of the Toolkit and sessions. DISCUSSION: If successful, the Live Well with Parkinson's Toolkit could be used as a model for other complex long-term disorders, including dementia. This would bridge existing gaps in the NHS (as shown by the national Parkinson's audit data), by enabling patients and carers to access personalised information, advice and support on symptom management and 'living well' with Parkinson's. TRIAL REGISTRATION: ISRCTN92831552. Registered on 26th Oct 2021.

Goal setting as part of a holistic intervention to promote independence in older people with mild frailty: a process evaluation alongside a randomised controlled trial.

BACKGROUND: Frailty is a condition resulting from a decline in physiological reserves caused by an accumulation of several deficits, which progressively impairs the ability to recover from health adverse events. Following a promising feasibility study, the HomeHealth trial assessed a holistic tailored intervention for older adults with mild frailty to promote independence in their own homes, compared with usual care. We aimed to understand how goal setting worked among older people with mild frailty. METHODS: This study was a process evaluation alongside the HomeHealth randomised trial in older adults with mild frailty. The intervention was delivered at participants' homes, either in person or by telephone or videoconferencing. We carried out semi-structured interviews with older participants who had received the intervention (between three and six appointments), on average 233 days (range 68-465) after their last appointment, purposively sampled according to age, gender, number of sessions attended, adverse events, ethnicity, Index of Multiple Deprivation, Montreal Cognitive Assessment (MoCA) and Barthel scores, research site, and HomeHealth worker. We also conducted interviews with HomeHealth workers who delivered the intervention (n=7). Interviews explored the experience and process of goal setting, benefits and challenges, perceived progress, and behaviour change maintenance after the service had finished. Ethics approval was obtained, and all participants gave informed consent. Interviews were thematically analysed. HomeHealth workers kept formal records of goals set and assessed progress towards goals (0-2 rating scale) during six monthly-sessions, which were descriptively summarised. FINDINGS: 56 interviews were completed between July 15, 2022, and May 18, 2023. Study participants (n=49) had a mean age of 80 years (range 66-94), including 32 (65%) women and 17 (35%) men. Participants self-identified as White (n=42), Asian (n=3), Black (n=2), Mixed (n=1), and other ethnic (n=1) backgrounds. Findings suggested goal setting could be both a challenge and a motivator for older participants with mild frailty. Goal setting worked well when the older person could identify a clear need and set realistic goals linked to functioning, which led to a positive sense of achievement. Challenges occurred when older people were already accessing multiple resources and health services, or where the terminology of "goals" was off-putting due to work or school connotations. Average progress towards goals was 1·15/2. Most participants set goals around improving mobility (or a combination of mobility and another goal type such as socialising), and there was evidence of participants sustaining these behaviour changes after the intervention. INTERPRETATION: Older people with mild frailty can engage well with goal setting to promote independence. The lapse between receiving the intervention and being interviewed limited recall for some participants. However, the acceptability and adherence to the intervention for older people with mild frailty, and their moderate progress towards goals, should encourage further tailored and person-centred practices to promote their independence. FUNDING: National Institute for Health Research (NIHR) Health Technology Assessment.

Type of goals set and progress towards these goals, as part of a behaviour change intervention, in people with mild cognitive impairment: a secondary analysis.

BACKGROUND: Mild cognitive impairment (MCI) affects 5-20% of older people in the UK, but often goes undiagnosed and is associated with increased risk of dementia. Targeting risk factors such as physical inactivity and social isolation through behaviour-change interventions could reduce this risk. However, it is unclear how MCI impacts engagement with these interventions. We aimed to explore how MCI affects goal-setting priorities and progress towards these goals in a behaviour-change intervention (HomeHealth). METHODS: This was a secondary analysis of a completed randomised controlled trial, HomeHealth, which started in January 2021 and recruited 386 participants aged 65 years and older with mild frailty according to the Clinical Frailty Scale from general practices and the community in England. Participants were randomly assigned (1:1) to receive either the HomeHealth intervention (n=195) or treatment as usual (n=191) for 6 months. An evidence-based behaviour change intervention supported older people to work on goals to maintain independence, addressing factors affecting capability, opportunity, and motivation. Goal setting and progress information was available for 167 (86%) of 195 participants who received the intervention. The type of goal set and goal progress (scale 0-2) were compared between participants with healthy cognition, those with potential MCI, and those with probable dementia (rated with Montreal Cognitive Assessment [MoCA]). Qualitative semi-structured interviews were conducted between Aug 16, 2022, and May 18, 2023, with 29 people with MCI who received the intervention, to explore the perceived impact of MCI on goal setting, progress, and maintenance. Data were analysed using codebook thematic analysis. FINDINGS: The mean age of participants was 80·8 years, 105 (63%) of 167 were women and 158 (95%) were white. 54 (32%) of 167 participants had healthy cognition, 94 (56%) had potential MCI, and 19 (11%) probable dementia. Distribution of goal type was similar across the three groups, with most participants setting mobility goals. Progress towards goals (scale 0-2) was similar in people with healthy cognition and potential MCI (1·24 and 1·18, respectively) but lower in those with probable dementia (0·76). However, all met the moderate progress cutoff (0·66-1·32). People with MCI recognised their cognition was getting worse but did not feel the HomeHealth intervention could help. Rather than setting new goals, people with MCI built on existing behaviours. Many did not initially understand the intervention and felt they would have benefitted from contact in between sessions or from more sessions to help goal progress. Once the sessions ended, less than a quarter of participants maintained the goal progress. INTERPRETATION: Interventions to help older adults age well can be successfully delivered in people with MCI, to help them set and make progress towards goals. However, to maintain changes, more intense support is needed. FUNDING: National Institute for Health and Care Research (NIHR) School for Primary Care Research, NIHR Health Technology Assessment.

Assessing the Acceptability and Effectiveness of Mobile-Based Physical Activity Interventions for Midlife Women During Menopause: Systematic Review of the Literature.

BACKGROUND: Midlife women with menopausal symptoms are less likely to meet the recommended level of physical activity (PA). Promoting PA among women in midlife could reduce their risk of cardiovascular diseases and perhaps improve menopausal symptoms. Mobile PA interventions in the form of smartphone apps and wearable activity trackers can potentially encourage users to increase PA levels and address time and resource barriers to PA. However, evidence on the acceptability and effectiveness of these interventions among midlife women is unclear. OBJECTIVE: This systematic review evaluated the effectiveness, acceptability, and active behavior change techniques (BCTs) of mobile PA technologies among midlife menopausal women. METHODS: A mixed methods systematic review of qualitative and quantitative studies was conducted. MEDLINE (Ovid), Embase, Scopus, CINAHL, Web of Science, SPORTDiscus, CENTRAL, PsycINFO, and the ProQuest Sports Medicine and Education Index were systematically searched. Studies were selected and screened according to predetermined eligibility criteria. In total, 2 reviewers independently assessed the risk of bias using the Mixed Methods Appraisal Tool and completed BCT mapping of the included interventions using the BCT Taxonomy v1. RESULTS: A total of 12 studies were included in this review. Overall risk of bias was "Moderate to high" in 58% (7/12) of the included studies and "low" in 42% (5/12) of the studies. Of the 12 studies, 7 (58%) assessed changes in PA levels. The pooled effect size of 2 randomized controlled trials resulted in a small to moderate increase in moderate to vigorous PA of approximately 61.36 weekly minutes among midlife women, at least in the short term (95% CI 17.70-105.01; P=.006). Although a meta-analysis was not feasible because of heterogeneity, positive improvements were also found in a range of menopause-related outcomes such as weight reduction, anxiety management, sleep quality, and menopause-related quality of life. Midlife women perceived mobile PA interventions to be acceptable and potentially helpful in increasing PA and daily steps. The average number of BCTs per mobile PA intervention was 8.8 (range 4-13) according to the BCT Taxonomy v1. "Self-monitoring of behaviour," "Biofeedback," and "Goal setting (behaviour)" were the most frequently described BCTs across the included interventions. CONCLUSIONS: This review demonstrated that mobile PA interventions in the form of smartphone apps and wearable trackers are potentially effective for small to moderate increases in moderate to vigorous PA among midlife women with menopausal symptoms. Although menopause is a natural condition affecting half the population worldwide, there is a substantial lack of evidence to support the acceptability and effectiveness of mobile PA interventions on menopause-related outcomes, which needs further investigation. TRIAL REGISTRATION: PROSPERO CRD42021273062; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=273062.

Reporting dose in complex self-management support interventions for long-term conditions: is it defined by researchers and received by participants? A systematic review.

BACKGROUND: The minimum clinically effective dose, and whether this is received in randomised controlled trials (RCTs) of complex self-management interventions in long-term conditions (LTCs), can be unclear. The Template for Intervention Description and Replication (TIDieR) checklist states that dose should be clearly reported to ensure validity and reliable implementation. OBJECTIVES: To identify whether the expected minimum clinically effective dose, and the dose participants received is reported within research articles and if reporting has improved since the TIDieR checklist was published. METHODS: Four databases were systematically searched (MEDLINE, PsycINFO, AMED and CINAHL) to identify published reports between 2008 and 2022 for RCTs investigating complex self-management interventions in LTCs. Data on reporting of dose were extracted and synthesised from the eligible articles. RESULTS: 94 articles covering various LTCs including diabetes, stroke and arthritis were included. Most complex interventions involved behaviour change combined with education and/or exercise. The maximum dose was usually reported (n=90; 97.8%), but the expected minimum clinically effective dose and the dose received were reported in only 28 (30.4%) and 62 (67.4%) articles, respectively. Reporting of the expected minimum clinically effective dose and the dose participants received did not improve following the publication of the TIDieR checklist in 2014. CONCLUSIONS: Interpreting results and implementing effective complex self-management interventions is difficult when researchers' reporting of dose is not in line with guidelines. If trial findings indicate benefit from the intervention, clear reporting of dose ensures reliable implementation to standard care. If the results are non-significant, detailed reporting enables better interpretation of results, that is, differentiating between poor implementation and lack of effectiveness. This ensures quality of interventions and validity and generalisability of trial findings. Therefore, wider adoption of reporting the TIDieR checklist dose aspects is strongly recommended. Alternatively, customised guidelines for reporting dose in complex self-management interventions could be developed. PROSPERO REGISTRATION NUMBER: CRD42020180988.

Measures of fidelity of delivery and engagement in self-management interventions: A systematic review of measures.

BACKGROUND/AIMS: Self-management interventions are increasingly being developed and researched to improve long-term condition outcomes. To understand and interpret findings, it is essential that fidelity of intervention delivery and participant engagement are measured and reported. Before developing fidelity checklists to assess treatment fidelity of interventions, current recommendations suggest that a synthesis of fidelity measures reported in the literature is completed. Therefore, here we aim to identify what the current measures of fidelity of intervention delivery and engagement for self-management interventions for long-term conditions are and whether there is treatment fidelity. METHODS: Four databases (MEDLINE, PubMed, CINAHL Plus and ScienceDirect) and the journal implementation science were systematically searched to identify published reports from inception to December 2020 for experimental studies measuring fidelity of intervention delivery and/or participant engagement in self-management interventions for long-term conditions. Data on fidelity of delivery and engagement measures and the findings were extracted and synthesised. RESULTS: Thirty-nine articles were identified as eligible, with 25 studies measuring fidelity of delivery, 19 reporting engagement and 5 measuring both. For fidelity of delivery, measures included structured checklists, participant completed measures and researcher observations/notes. These were completed by researchers, participants and intervention leaders. Often there was little information around the development of these measures, particularly when the measure had been developed by the researchers, rather than building on others work. Eighteen of 25 studies reported there was fidelity of intervention delivery. For engagement, measures included data analytics, participant completed measures and researcher observations. Ten out of 19 studies reported participants were engaged with the intervention. CONCLUSION: In complex self-management interventions, it is essential to assess whether treatment fidelity of each core component of interventions is delivered, as outlined in the protocol, to understand which components are having an effect. Treatment fidelity checklists comparing what was planned to be delivered, with what was delivered should be developed with pre-defined cut-offs for when fidelity has been achieved. Similarly, when measuring engagement, while data analytics continue to rise with the increase in digital interventions, clear cut-offs for participant use and content engaged with to be considered an engagement participant need to be pre-determined.