Why did an effective Dutch complex psycho-social intervention for people with dementia not work in the German healthcare context? Lessons learnt from a process evaluation alongside a multicentre RCT

Contains fulltext : 97517.pdf (publisher's version ) (Open Access)Background The positive effects of the Dutch Community Occupational Therapy in Dementia programme on patients' daily functioning were not found in a multicentre randomised controlled trial (RCT) in Germany. Objectives To evaluate possible effect modification on the primary outcome within the German RCT with regard to (1) participant characteristics, (2) treatment performance and (3) healthcare service utilisation; and (4) to compare the design and primary outcome between the German and the original Dutch study. Methods (1) The impact of participant baseline data on the primary outcome was analysed in exploratory ANCOVA and regression analyses. (2) Therapists completed questionnaires on context and performance problems. The main problems were identified by a qualitative content analysis and focus-group discussion. Associations of the primary outcome with scores of participant adherence and treatment performance were evaluated by regression analysis. (3) Utilisation rates of healthcare services were controlled for significant group differences. (4) Differences in the Dutch and German study design were identified, and the primary outcome was contrasted at the item level. Results (1) Participant characteristics could not explain more than 5% of outcome variance. (2) The treatment performance of some active intervention components was poor but not significantly associated with the primary outcome. (3) There were no significant group differences in the utilisation of healthcare resources. (4) In contrast to the Dutch waiting-control group, the active intervention in the German control group may have reduced group differences in the current RCT. The German patients demonstrated a higher independence at baseline and less improvement in instrumental activities of daily living. Conclusion The differences in outcome may be explained by a more active control treatment, partially poor experimental treatment and less room for improvement in the German sample. Future cross-national transfers should be prepared by pilot studies assessing the applicability of the intervention and patient needs specific to the target country. Trial registration International Clinical Trials Registry Platform, DRKS00000053

A proposal for the retrospective identification and categorization of older people with functional impairments in scientific studies : recommendations of the Medication and Quality of Life in Frail Older Persons (MedQoL) research group

When treating older adults, a main factor to consider is physical frailty. Because specific assessments in clinical trials are frequently lacking, critical appraisal of treatment evidence with respect to functional status is challenging. Our aim was to identify and categorize assessments for functional status given in clinical trials in older adults to allow for a retrospective characterization and indirect comparison of treatment evidence from these cohorts. We conducted 4 separate systematic reviews of randomized and nonrandomized controlled clinical trials in older people with hypertension, diabetes, depression, and dementia. All assessments identified that reflected functional status were analyzed. Assessments were categorized across 4 different functional status levels. These levels span from functionally not impaired, slightly impaired, significantly impaired, to severely impaired/disabled. If available from the literature, cut-offs for these 4 functioning levels were extracted. If not, or if the existing cut-offs did not match the predefined functional levels, cut-off points were defined by an expert group composed of geriatricians, pharmacists, pharmacologists, neurologists, psychiatrists, and epidemiologists using a patient-centered approach. We identified 51 instruments that included measures of functional status. Although some of the assessments had clearly defined cut-offs across our predefined categories, many others did not. In most cases, no cut-offs existed for slightly impaired or severely impaired older adults. Missing cut-offs or values to adjust were determined by the expert group and are presented as described. The functional status assessments that were identified and operationalized across 4 functional levels could now be used for a retrospective characterization of functional status in randomized controlled trials and observational studies. Allocated categories only serve as approximations and should be validated head-to-head in future studies. Moreover, as general standard, upcoming studies involving older adults should include and explicitly report functional impairment as a baseline characteristic of all participants enrolled

Taking a positive spin: preserved initiative and performance of everyday activities across mild Alzheimer’s, vascular, and mixed dementia

Objectives: The literature commonly evaluates those daily activities which are impaired in dementia. However, in the mild stages, people with dementia (PwD) are still able to initiate and perform many of those tasks. With a lack of research exploring variations between different dementia diagnoses, this study sought to investigate those daily activities with modest impairments in the mild stages and how these compare between Alzheimer's disease (AD), vascular dementia (VaD) and mixed dementia. Methods: Staff from memory assessment services from nine National Health Service trusts across England identified and approached informal carers of people with mild dementia. Carers completed the newly revised Interview for Deteriorations in Daily Living Activities in Dementia 2 assessing the PwD's initiative and performance of instrumental activities of daily living (IADLs). Data were analysed using analysis of variance and Chi-square tests to compare the maintenance of IADL functioning across AD, VaD, and mixed dementia. Results: A total of 160 carers returned the Interview for Deteriorations in Daily Living Activities in Dementia 2, of which 109, 21, and 30 cared for someone with AD, VaD, and mixed dementia, respectively. There were significant variations across subtypes, with AD showing better preserved initiative and performance than VaD for several IADLs. Overall, PwD showed greater preservation of performance than initiative, with tasks such as preparing a hot drink and dressing being best maintained. Conclusion: Findings can help classify dementia better into subtypes in order to receive bespoke support. It suggests that interventions should primarily address initiative to improve overall functioning

Initiating activities of daily living contributes to well-being in people with dementia and their carers

Objective: Problems with everyday functioning are linked to reduced well-being in people with dementia (PwD) and their carers. However, previous research has almost solely investigated the performance of everyday activities, and global functioning without analysing individual activities. This study explored how deficits in initiating and performing individual activities were associated with carer burden and poorer quality of life of carers and PwD. Methods: Carers of people with mild dementia were recruited via 10 National Health Service Trusts, as well as through attending six carer support groups. Carers were asked to complete the revised Interview for Deteriorations in Daily Living Activities in Dementia 2 (R-IDDD2), and measures on carer burden, well-being, and person with dementia well-being. Data were analysed using correlation analysis. Results: Two hundred and seventy-two carers completed the R-IDDD2. Carers were grouped into those with low or high ratings of well-being based on the mean scores. All but three activities on the initiative and/or performance scale were significantly associated with carer burden and carer and PwD quality of life. Engaging in hobbies and maintaining an active social life were most strongly associated with carer and PwD well-being. Initiating computer use, driving, and medication management were not related to carer burden. Conclusions: Findings from this study can have direct implications for improving care management early in the disease. Post-diagnostic support needs to provide more opportunities for PwD, and their carers, to engage in social groups, whilst interventions targeted at living well with dementia need to particularly improve the initiative of engaging in individual hobbies. © 2017 The Authors. International Journal of Geriatric Psychiatry published by John Wiley & Sons Ltd

Occupational Therapy, Self-Efficacy, Well-Being in Older Adults Living in Residential Care Facilities: A Randomized Clinical Trial

Choosing the type of treatment approach is as important as the treatment itself, also giving and important value to internal variables in the individual that can determine the evolution of the intervention. The main aim of this study is to determine whether individual and/or group occupational therapy leads to changes in generalized self-efficacy and psychological well-being, and to identify the type of therapy that has the best effects on older adults. Groups were equivalent at baseline. The results show statistically significant differences between the two types of therapy, showing a positive correlation between well-being and self-efficacy, being greater at a group level than at and individual level. At the group level, practically all of variables measured in the participants were increased as shown in the results tables, including a better adaptation and predisposition to work four participants died while the study was being conducted. The clinical trial shows that older people in residential centers achieve an increase in emotional well-being and self-efficacy when they receive occupational therapy group, rather than individual treatment not being significant changes. Treatment group participants reported a positive experience and clinical benefits from training program

Study protocol of the multi-site randomised controlled REDALI-DEM trial - The effects of structured Relearning methods on Daily Living task performance of persons with Dementia

<p>Abstract</p> <p>Background</p> <p>Evidence from pilot trials suggests that structured learning techniques may have positive effects on the performance of cognitive tasks, movement sequences or skills in patients with Alzheimer's disease. The purpose of this trial is to evaluate whether the usual method of learning by trial and error or the method of errorless learning demonstrate better effects on the performance of two selected daily living tasks six weeks after the intervention in people with mild to moderate dementia.</p> <p>Methods/Design</p> <p>A seven-centre single-blind, active-controlled design with a 1:1 randomisation for two parallel groups will include 175 persons diagnosed with Alzheimer's disease or mixed type dementia (MMSE 14-24), living at home, showing at least moderate need for assistance in instrumental activities of daily living; primary carer available and informed consent of patient and primary carer. Patients of both study arms will receive 15 one-hour-sessions at home by trained interventionists practising two daily living tasks individually selected. In one group the trial and error technique and in the other group the errorless learning method will be applied. Primary outcome is the task performance measured with the Task Performance Scale six weeks post treatment.</p> <p>Discussion</p> <p>The trial results will inform us to improve guidelines for instructing individuals with memory impairments. A user-friendly practice guideline will allow an efficient implementation of structured relearning techniques for a wide range of service providers in dementia care.</p> <p>Trial registration</p> <p>DRKS00003117</p

Psychosocial interventions for community-dwelling people following diagnosis of mild to moderate dementia: findings of a systematic scoping review

National policies and evidence reviews recommend psychosocial interventions (PIs) as an essential support, particularly in the period following dementia diagnosis. However, availability and uptake of these interventions are comparatively low. One of the reasons for this is that clinicians lack information about what might be provided and the potential benefits of different interventions. This article identifies and describes PIs for community-dwelling people following diagnosis of mild to moderate dementia and presents the available evidence to inform practice decisions. A systematic scoping review was employed to map the evidence relating to PIs for this group. This identified 63 relevant studies, testing 69 interventions, which could be grouped into 6 intervention categories: 20 cognition-oriented, 11 behavior-oriented, 11 stimulation-oriented, 13 emotion-oriented, 5 social-oriented, and 9 multimodal. There were three targets for outcome measurement of these PIs: the person with dementia, the family caregiver, and the person–caregiver dyad. Over 154 outcome measures were identified in the studies, with outcomes measured across 11 main domains. The lack of a classification framework for PIs means it is difficult to create a meaningful synthesis of the breadth of relevant evidence to guide clinical practice. Possible dimensions of a classification framework are proposed to begin to address this gap

WHEDA study: Effectiveness of occupational therapy at home for older people with dementia and their caregivers - the design of a pragmatic randomised controlled trial evaluating a Dutch programme in seven German centres

Contains fulltext : 80941.pdf (publisher's version ) (Open Access)BACKGROUND: A recent Dutch mono-centre randomised controlled trial has shown that occupational therapy improves daily functioning in dementia. The aim of this present study is to compare the effects of the Dutch community occupational therapy programme with a community occupational therapy consultation on daily functioning in older people with mild or moderate dementia and their primary caregivers in a German multi-centre context. METHODS/DESIGN: A multi-centre single blind randomised controlled trial design is being used in seven health care centres (neurological, psychiatric and for older people) in urban regions. Patients are 1:1 randomised to treatment or control group. Assessors are blind to group assignment and perform measurements on both groups at baseline, directly after intervention at 6 weeks and at 16, 26 and 52 weeks follow-up. A sample of 140 community dwelling older people (aged >65 years) with mild or moderate dementia and their primary caregivers is planned. The experimental intervention consists of an evidence-based community occupational therapy programme including 10 sessions occupational therapy at home. The control intervention consists of one community occupational therapy consultation based on information material of the Alzheimer Society. Providers of both interventions are occupational therapists experienced in treatment of cognitively impaired older people and trained in both programmes. 'Community' indicates that occupational therapy intervention occurs in the person's own home. The primary outcome is patients' daily functioning assessed with the performance scale of the Interview for Deterioration in Daily Living Activities in Dementia and video tapes of daily activities rated by external raters blind to group assignment using the Perceive, Recall, Plan and Perform System of Task Analysis. Secondary outcomes are patients' and caregivers' quality of life, mood and satisfaction with treatment; the caregiver's sense of competence, caregiver's diary (medication, resource utilisation, time of informal care); and the incidence of long-term institutionalisation. Process evaluation is performed by questionnaires and focus group discussion. DISCUSSION: The transfer from the Dutch mono-centre design to the pragmatic multi-site trial in a German context implicates several changes in design issues including differences in recruitment time, training of interventionists and active control group treatment.The study is registered under DRKS00000053 at the German register of clinical trials, which is connected to the International Clinical Trials Registry Platform