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

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

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

Potential analysis for research on occupational therapy-led physical exercise programmes and home environment adaptation programmes to prevent falls for elderly people living at home / Potenzialanalyse zu ergotherapeutischen körperlichen Trainingsprogrammen und Wohnraumanpassungen zur Vermeidung von Stürzen bei zu Hause lebenden älteren Menschen

In Germany, four to five million community-dwelling people aged 65 years or older fall every year. The presented potential analysis evaluates the potential of occupational therapy-led physical exercise programs and home environment adaptations to reduce the frequency of falling and as well as intrinsic and extrinsic risk factors for falling of older people living at home

REGIO-GERIATRIE — multiprofessionell koordiniert versorgt

In United Kingdom care homes (CHs), multi-compartment compliance aid (MCA) medicine management systems are more commonly used than original medicine packaging (OP), to organise and administer the large volume of medicines used by residents. This study aimed to understand how these two systems (MCAs and OP) impact on CH medicine administration. This was a mixed methods study. The quantitative component involved direct observation to identify discrepancies in medicine administration. The qualitative component involved an ethnographic approach and interviews to understand the medicine administration process and identify associated barriers/facilitators. In September and October 2014, a pharmacist researcher spent 1-3 days observing 17 nurses administer medicines and interviewing 15 nurses, at 4 purposively sampled CHs around Greater London that used either MCAs or OP. Ethical approval was obtained from the University College London Research Ethics Committee. The ethnographic approach allowed the researcher to immerse themselves into the work environment of the nurses. This facilitated a comprehensive understanding of the MCA and OP medicine management systems under research, at all times of the day and under all possible work conditions that could arise. The observations allowed the researcher to identify practices that may contribute to medicine administration discrepancies. These practices may not have been discussed at all, or in any great detail, during nurse interviews. Potential challenges of this qualitative research include participant apprehensiveness concerning the observations in general, or observations interfering with daily work practices. These were managed by ensuring observations were minimally intrusive and all participating CHs and nurses remained anonymous. The qualitative research methods used in this study helped explain the quantitative data and provided a rich and comprehensive understanding of the systems under research, which is unlikely to have occurred using quantitative research methods alone

Betrouwbaarheid van de PRPP-beoordeling bij thuiswonende patiënten met dementie: consistentietest en inter-beoordelaarsovereenkomst

Achtergrond: Het doel van deze studie is het evalueren van de aspecten van interbeoordelaarsbetrouwbaarheid van het PRPP-systeem (Perceive, Recall, Plan en Perform) van Taakanalyse voor het beoordelen van het dagelijks functioneren van thuiswonende patiënten met dementie. Methode: Video-opnames van 30 Duitse patiënten met dementie die een betekenisvolle dagelijkse taak uitvoeren in hun eigen woning werden onafhankelijk beoordeeld door 10 Nederlandse ergotherapeuten opgeleid in PRPP, willekeurig geselecteerd uit een groep van 25. Intra-class correlaties (ICC) (one-way single measure) werden berekend voor PRPP Stage One- onafhankelijkheidsscore, en PRPP Stage Two informatieverwerkingsschaal, kwadrantschalen en subkwadrantschalen van in totaal 300 PRPP-scores. Conclusies: De PRPP is een betrouwbare meting om de individuele prestaties van routines en taken bij patiënten met dementie die in de gemeenschap leven te beoordelen door meerdere beoordelaars. Verder onderzoek is nodig om de kenmerken van betrouwbaarheid en validiteit van de PRPP voor patiënten met dementie na te gaan, met inbegrip van criterion-referenced testkarakteristieken