Project description:IntroductionNew Interventions for independence in Dementia Study (NIDUS)-Family is an Alzheimer's Society funded new manualised, multimodal psychosocial intervention to support people living with dementia (PLWD) to achieve goals that they and their family carers set, towards living as independently and as well as possible at home for longer. This process evaluation will be embedded within the NIDUS-Family Randomised Controlled Trial intervention-arm (n=199), testing how the intervention influences change, as measured by goal attainment. The evaluation will test, refine and develop the NIDUS-Family theoretical model, associated causal assumptions and logic model to identify key mechanisms of impact, implementation and contextual factors influencing the intervention's effectiveness. Findings will inform how the programme is implemented in practice.Methods and analysisThe process evaluation will be theory driven and apply a convergent mixed-methods design. Dyads (PLWD and family carer) will be purposively sampled based on high or low Goal Attainment Scaling scores (trial primary outcome). Qualitative interviews with dyads (approx. n=30) and their respective facilitators post-trial will explore their experiences of receiving and delivering the intervention. Interviews will be iteratively thematically analysed. Matching observational quantitative data will be collected concurrently from videorecordings and/or audiorecordings of NIDUS-Family dyad trial sessions. Further quantitative data will be collected through an acceptability questionnaire for all intervention-arm dyads (n=199). Mixed-method integration will use an interactive analysis strategy, considering qualitative and quantitative findings through mixed-method matrix for dyadic level 'case studies', and a joint display for 'population' level analysis and interpretation.Ethics and disseminationEthical approval was received from Camden & Kings Cross Research Ethics Committee (REC). Study reference: 19/LO/1667. IRAS project ID: 271 363. This work is carried out within the UCL Alzheimer's Society Centre of Excellence (grant 300) for Independence at home, NIDUS programme.Findings will be disseminated through publications and conferences, and as recommendations for the implementation study and strategy.Trial registration numberISRCTN11425138.

Project description:BackgroundAlthough goal setting and goal management (GSGM) is a key component of chronic disease management and rehabilitation practice, there is currently no widely used evidence-based intervention system available. This paper describes the theoretical underpinnings and development of a new intervention called MyGoals. MyGoals is designed to guide occupational therapy (OT) practitioners to implement theory-based, client-engaged GSGM for adults with chronic conditions in community-based OT rehabilitation settings.MethodsWe first developed a planning team with two adults with chronic conditions, two clinicians, and two researchers. As a collaborative team, we co-developed MyGoals by following Intervention Mapping (IM) steps 1-4 and incorporating community-based participatory research principles to ensure equitable, ecologically valid, and effective intervention development. In the first step, the planning team conducted a discussion-based needs assessment and a systematic review of current GSGM practice to develop a logic model of the problem. In the second step, the planning team identified performance objectives, intervention target personal determinants, and change objectives, and created a logic model of change and matrics of change objectives. In the third step, the planning team designed MyGoals. Lastly, in the fourth step, the planning team produced, pilot-tested, and refined MyGoals.ResultsThe ultimate goal of the MyGoals intervention is to enable clients to achieve personally meaningful rehabilitation goals. The planning team identified four target determinants (e.g., self-efficacy), six intervention activities (e.g., Education, Reflection, Find My Goals, Make My Goals, Make My Plans, My Progress), eight performance objectives (e.g., List potential goals), and 26 change objectives (e.g., Understand the importance of GSGM). Two pilot tests indicated that MyGoals is feasible for clients and identified areas for improvement. Based on the feedback, minor refinements were made to the MyGoals intervention materials.ConclusionsWe completed rigorous and collaborative IM to develop MyGoals. Establishing the theoretical and developmental foundation for MyGoals sets the groundwork for high-quality, evidence-based GSGM. Future studies on effectiveness and implementation are necessary to refine, translate, and scale MyGoals in rehabilitation practice.

Project description:BackgroundIndividualised goal-setting outcome measures can be a useful way of reflecting people living with dementia and family carers' differing priorities regarding quality-of-life domains in the highly heterogeneous symptomatology of the disease. Evaluating goal-setting measures is challenging, and there is limited evidence for their psychometric properties.Aim(1) To describe what goal-setting outcomes have been used in this population; (2) To evaluate their validity, reliability, and feasibility in RCTs.MethodWe systematically reviewed studies that utilised goal-setting outcome measures for people living dementia or their family carers. We adapted a risk of bias and quality rating system based on the COSMIN guidelines to evaluate the measurement properties of outcomes when used within RCTs.ResultsThirty studies meeting inclusion criteria used four different goal-setting outcome measures: Goal Attainment Scaling (GAS), Bangor Goal Setting Interview (BGSI), Canadian Occupational Performance Measure (COPM) and Individually Prioritized Problems Assessment (IPPA); other papers have reported study-specific goal-setting attainment systems. Only GAS has been used as an outcome over periods greater than 9 months (up to a year). Within RCTs there was moderate quality evidence for sufficient content validity and construct validity for GAS, COPM and the BGSI. Reliability was only assessed in one RCT (using BGSI); in which two raters reviewed interview transcripts to rate goals with excellent inter-rater reliability. Feasibility was reported as good across the measures with a low level of missing data.ConclusionWe found moderate quality evidence for good content and construct validity and feasibility of GAS, BGSI and COPM. While more evidence of reliability of these measures is needed, we recommend that future trials consider using individualised goal setting measures, to report the effect of interventions on outcomes that are most meaningful to people living with dementia and their families.

Project description:BackgroundThere is a need for an effective evidence-based system to support high-quality goal setting and goal management implementation. We developed a new system for community-based rehabilitation, MyGoals, along with implementation strategies to support occupational therapists (OTs) in its administration. This study evaluates the acceptability, appropriateness, and feasibility of the implementation strategies, Clinician Education and Audit & Feedback. It also explores whether OTs achieve the change objectives of the MyGoals implementation strategies and MyGoals intervention fidelity.MethodsThis mixed-methods case series study evaluated the MyGoals implementation strategies developed using Implementation Mapping (IM), specifically IM Task 5 - Implementation Outcome Evaluation. Seven OTs and 13 adults with chronic conditions participated in this study. OTs participated in two Clinician Education sessions, delivered two MyGoals interventions, and participated in two Audit & Feedback sessions. We evaluated the implementation strategies using the Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), Feasibility of Intervention Measure (FIM), and semi-structured interviews and explored the OTs' self-rated MyGoals change objectives achievement and the intervention fidelity using quantitative MyGoals intervention fidelity measures and interviews. Quantitative data were analyzed using descriptive statistics. Qualitative data were analyzed by two independent coders using content analysis.ResultsSeven OTs participated in this study (mean years of professional experience = 9.3, SD = 5.9). Clinician Education and Audit & Feedback had high AIM (M = 17.9, SD = 2.7), IAM (M = 17.3, SD = 3.60), and FIM scores (M = 17.3, SD = 3). The OTs also had high mean scores on self-perceived achievement of change objectives and intervention fidelity. Qualitative interviews suggested that the time commitment for Clinician Education is a key barrier to its acceptability, appropriateness, and feasibility. Participants also provided suggestions on how to improve the strategies (e.g., providing recorded Clinician Education, etc.).ConclusionsThe MyGoals implementation strategies are acceptable, appropriate, and feasible to OTs working in community-based rehabilitation. They support OTs in achieving the change objectives necessary to deliver MyGoals completely and competently. Thus, the MyGoals implementation strategies may support clinicians in implementing a theory-based, client-engaged goal setting and goal management for adults with chronic conditions in community-based rehabilitation. This can ultimately help improve the integration of evidence-based interventions into practice.

Project description:ImportanceThere is no evidence-based system to guide occupational therapists in implementing theory-based, client-engaged goal setting and goal management. A new system is needed to support high-quality goal setting and goal management.ObjectiveTo determine the acceptability, appropriateness, feasibility, credibility, and expectancy of a new structured theory-based, client-engaged goal setting and goal management system, called MyGoals, for occupational therapists. We explored MyGoals' implementation determinants, potential positive outcomes, and comparative advantages.DesignThis was a mixed-methods feasibility study.SettingCommunity.ParticipantsOccupational therapists (N = 7).Outcomes and measuresAcceptability, appropriateness, and feasibility were assessed using the Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM). Credibility and expectancy were assessed with the Credibility and Expectancy Questionnaire (CEQ). Semistructured 1:1 interviews were conducted to explore occupational therapy perspectives on MyGoals and its implementation-related factors.ResultsMyGoals had high AIM (M = 18.1, SD = 1.9), IAM (M = 17.9, SD = 2.2), FIM (M = 17.3, SD = 2.1) scores and high CEQ Credibility (M = 22.1, SD = 5.0) and Expectancy (M = 20.6, SD = 4.3) scores. Interview data revealed suggestions to improve MyGoals, implementation determinants across the individuals involved, inner setting, and intervention characteristic domains, client- and clinician-related potential positive outcomes, and comparative advantages.Conclusions and relevanceMyGoals is an acceptable, appropriate, feasible, credible, and promising system to guide occupational therapists in implementing theory-based, client-engaged goal setting and goal management for adults with chronic conditions in community-based rehabilitation. What This Article Adds: MyGoals is an easy-to-use, appealing, and helpful system to support occupational therapists in delivering theory-based goal setting and goal management components and to enable adults with chronic conditions to actively engage in their rehabilitation. This study supports the usefulness of MyGoals in community-based rehabilitation to improve goal setting and goal management quality and personally meaningful rehabilitation goal achievement in this population.

Project description:BackgroundStepped and Collaborative Care Models (SCCMs) have shown potential for improving mental health care. Most SCCMs have been used in primary care settings. At the core of such models are initial psychosocial distress assessments commonly in form of patient screening. We aimed to assess the feasibility of such assessments in a general hospital setting in Switzerland.MethodsWe conducted and analyzed eighteen semi-structured interviews with nurses and physicians involved in a recent introduction of a SCCM model in a hospital setting, as part of the SomPsyNet project in Basel-Stadt. Following an implementation research approach, we used the Tailored Implementation for Chronic Diseases (TICD) framework for analysis. The TICD distinguishes seven domains: guideline factors, individual healthcare professional factors, patient factors, professional interactions, incentives and resources, capacity for organizational change, and social, political, and legal factors. Domains were split into themes and subthemes, which were used for line-by-line coding.ResultsNurses and physicians reported factors belonging to all seven TICD domains. An appropriate integration of the psychosocial distress assessment into preexisting hospital processes and information technology systems was the most important facilitator. Subjectivity of the assessment, lack of awareness about the assessment, and time constraints, particularly among physicians, were factors undermining and limiting the implementation of the psychosocial distress assessment.ConclusionsAwareness raising through regular training of new employees, feedback on performance and patient benefits, and working with champions and opinion leaders can likely support a successful implementation of routine psychosocial distress assessments. Additionally, aligning psychosocial distress assessments with workflows is essential to assure the sustainability of the procedure in a working context with commonly limited time.

Project description:Group-based psychosocial therapy, such as group Cognitive Stimulation Therapy, improves cognition and quality of life in people living with dementia. Neuropsychiatric symptoms and restricted mobility are common complications for people with Parkinson's-related dementia (PRD) and may limit access to, and participation in, group activities. This study describes the development of a condition-specific, home-based psychosocial therapy for people with PRD ready to be trialled in a clinical population.By means of a multistage process, a draft therapy manual was developed in an iterative manner through collaboration with medical experts, researchers and Patient and Public Involvement (PPI) representatives. In stage 1, an extensive literature search of psychosocial therapies for dementia with potential relevance for Parkinson's disease (PD) was undertaken to select a candidate therapy for adaptation. In stage 2, qualitative feedback from stakeholders and intelligence regarding existing nonpharmacological therapies for cognitive impairment in PD was combined to produce a prototype therapy manual. In stage 3, the manual was field tested in: 1) a home-setting using a 25-item assessment tool; and 2) at a local PD support group with PPI representatives. Based on the feedback from this phase, final design modifications were implemented and a draft therapy manual produced.The manual was developed in an iterative manner. Interview and focus group transcripts identified three enduring themes: manual form and content, therapy acceptability by people with PRD, and companion guidance and support. Major adaptations included: removal of discrete levels of task complexity, removal of images that were potentially hallucinogenic or lacked clarity, and updating of the content.We have successfully developed a Cognitive Stimulation Therapy-based psychosocial therapy specifically adapted for people with PRD. The therapy is ready to trial in a pilot randomized controlled study.

Project description:BackgroundLewy body dementia (LBD) is an aggressive type of dementia of rapid, fluctuating disease trajectory, higher incidence of adverse events, and poorer functional independence than observed in Alzheimer's disease dementia. Non-pharmacological treatments such as progressive, high-intensity exercise are effective in other neurological cohorts but have been scarcely evaluated in LBD.MethodsThe Promoting Independence in Lewy Body Dementia through Exercise (PRIDE) trial was a non-randomised, non-blinded, crossover pilot trial involving older adults with LBD consisting of a baseline assessment, an 8-week wait-list, and an 8-week exercise intervention. The aims of this study were to evaluate the determinants of the primary outcome functional independence, as measured by the Movement Disorder Society Unified Parkinson's Disease Rating Scale, and the feasibility and preliminary efficacy of an exercise intervention on this outcome. Additionally, important clinical characteristics were evaluated to explore associations and treatment targets. The exercise intervention was supervised, clinic-based, high-intensity progressive resistance training (PRT), challenging balance, and functional exercises, 3 days/week.ResultsNine participants completed the baseline cross-sectional study, of which five had a diagnosis of Parkinson's disease dementia (PDD), and four dementia with Lewy Bodies (DLB). Six completed the exercise intervention (three PDD, three DLB). The cohort was diverse, ranging from mild to severe dementia and living in various residential settings. Greater functional independence at baseline was significantly associated with better physical function, balance, cognition, quality of life, muscle mass ratio, walking endurance, faster walking speed and cadence, and lower dementia severity (p < 0.05). Participants declined by clinically meaningful amounts in functional independence, cognition, physical function, muscle mass, and weight over the wait-list period (p < 0.05). Following exercise, participants improved by clinically meaningful amounts in functional independence, cognition, physical function, and strength (p < 0.05). Progressive, high intensity exercise was well-tolerated (> 80% adherence), and only one minor exercise-related adverse event occurred.ConclusionsPRIDE is the first exercise trial conducted specifically within individuals diagnosed with LBD, and provides important insight for the design of larger, randomized trials for further evaluation of progressive, high-intensity exercise as a valuable treatment in LBD.Trial registrationThe PRIDE trial protocol has previously been prospectively registered (08/04/2016, ANZCTR: ACTRN12616000466448).

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A psychosocial goal-setting and manualised support intervention for independence in dementia (NIDUS-Family) versus goal setting and routine care: a single-masked, phase 3, superiority, randomised controlled trial

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