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

Validation of the Patient Health Questionnaire‐4 for longitudinal mental health evaluation in elite Para athletes

Background Despite the increasing amount of research regarding mental health in elite athletes in recent years, athletes with impairments are hardly represented. Due to this lack of data and the significant need of athlete-specific mental health screening tools, a continuous mental health monitoring program for elite Para athletes was implemented. Objective Validation of the Patient Health Questionnaire-4 (PHQ-4) as a suitable tool for continuous mental health evaluation in elite Para athletes. Design A 43-week prospective observational cohort study. Setting Online questionnaire, provided weekly via web browser and mobile app. Participants Seventy-eight Para athletes preparing for Paralympic Summer and Winter Games. Interventions Not applicable. Main Outcome Measures Weekly PHQ-4 scores, stress level, and mood. Results With a mean weekly response rate of 82.7% (SD = 8.0), 2149 PHQ-4, 2159 stress level and 2153 mood assessments were completed. Mean PHQ-4 score among all participating athletes was 1.2 (SD = 1.8; 95% confidence interval [CI], [1.1–1.3]). Individual weekly scores ranged from 0 to 12 and showed significant floor effects, with 54% of the scores being zero. PHQ-4 scores were significantly higher among female athletes and team sport members (p < .001). Internal consistency of the PHQ-4 was satisfying, Cronbach's α being 0.839. There were significant cross-sectional as well as longitudinal correlations of PHQ-4 and stress level as well as mood values (p < .001). 39.7% of all athletes (n = 31) had at least one positive screen for mental health symptoms. Conclusions The PHQ-4 was shown to be a valid tool for mental health surveillance in elite Para athletes. Significant correlations of the PHQ-4 and stress level as well as mood were shown. High weekly response rates among participating athletes indicated good acceptance of the program. The weekly monitoring allowed for the identification of individual fluctuations and could identify potential athletes at risk for mental health problems when combined with clinical follow-up

Web-Based Randomized Controlled Trial

Background: Patients often seek other patients’ experiences with the disease. The Internet provides a wide range of opportunities to share and learn about other people’s health and illness experiences via blogs or patient-initiated online discussion groups. There also exists a range of medical information devices that include experiential patient information. However, there are serious concerns about the use of such experiential information because narratives of others may be powerful and pervasive tools that may hinder informed decision making. The international research network DIPEx (Database of Individual Patients’ Experiences) aims to provide scientifically based online information on people’s experiences with health and illness to fulfill patients’ needs for experiential information, while ensuring that the presented information includes a wide variety of possible experiences. Objective: The aim is to evaluate the colorectal cancer module of the German DIPEx website krankheitserfahrungen.de with regard to self-efficacy for coping with cancer and patient competence. Methods: In 2015, a Web-based randomized controlled trial was conducted using a two-group between-subjects design and repeated measures. The study sample consisted of individuals who had been diagnosed with colorectal cancer within the past 3 years or who had metastasis or recurrent disease. Outcome measures included self-efficacy for coping with cancer and patient competence. Participants were randomly assigned to either an intervention group that had immediate access to the colorectal cancer module for 2 weeks or to a waiting list control group. Outcome criteria were measured at baseline before randomization and at 2 weeks and 6 weeks Results: The study randomized 212 persons. On average, participants were 54 (SD 11.1) years old, 58.8% (124/211) were female, and 73.6% (156/212) had read or heard stories of other patients online before entering the study, thus excluding any influence of the colorectal cancer module on krankheitserfahrungen.de. No intervention effects were found at 2 and 6 weeks after baseline. Conclusions: The results of this study do not support the hypothesis that the website studied may increase self-efficacy for coping with cancer or patient competencies such as self-regulation or managing emotional distress. Possible explanations may involve characteristics of the website itself, its use by participants, or methodological reasons. Future studies aimed at evaluating potential effects of websites providing patient experiences on the basis of methodological principles such as those of DIPEx might profit from extending the range of outcome measures, from including additional measures of website usage behavior and users’ motivation, and from expanding concepts, such as patient competency to include items that more directly reflect patients’ perceived effects of using such a website. Trial Registration: Clinicaltrials.gov NCT02157454; https://clinicaltrials.gov/ct2/show/NCT02157454 (Archived by WebCite at http://www.webcitation.org/6syrvwXxi

Mental Health in German Paralympic Athletes During the 1st Year of the COVID-19 Pandemic Compared to a General Population Sample

Introduction: The COVID-19 pandemic has huge influences on daily life and is not only associated with physical but also with major psychological impacts. Mental health problems and disorders are frequently present in elite paralympic athletes. Due to the pandemic situation, new stressors (e.g., loss of routine, financial insecurity) might act upon the athletes. Therefore, the assessment of mental health in athletes during the COVID-19 pandemic is important to identify prevalence of psychological problems and propose countermeasures. Methods: The mental health of German paralympic athletes was longitudinally monitored (starting in May 2019). The athletes completed the Patient Health Questionnaire 4 (PHQ-4) on a weekly basis and reported a stress level, training hours, and training load. During the pandemic, 8 measurement time points (March 2020 to April 2021) were used to reflect the psychological health course of the athletes. In parallel, a convenience sample of the general population was questioned about their psychological distress, including the PHQ-4. To be included in the analysis, participants of both groups had to complete at least 4 measurement time points. Matching of the para-athletes and the general population sample was prioritized upon completion of the same measurement time points, gender, and age. Results: Seventy-eight paralympic athletes (40 women, 38 men, age: 29.8 ± 11.4 years) met the inclusion criteria. Seventy-eight matched pairs of the general population (40 women; 38 men; age: 30.5 ± 10.9 years) were identified. The para-athletes had a significantly (p < 0.0001; 0.39 < r < 0.48) lower PHQ-4 value at each measurement time point compared to the matched control group. No significant age or sex differences were evident regarding the symptom burden. In para-athletes, no significant and a weak positive correlation was found between decreased training load and PHQ-4 values and Mental Health in Para-Athletes During COVID-19 a stress level, respectively. Reduced physical activity was significantly (p < 0.0001) associated with higher PHQ-4 values in the general population sample. Discussion: Lower PHQ-4 values were reported by the para-athletes compared to the general population sample. However, small sample sizes must be considered while interpreting the data. Nevertheless, adequate support for individuals suffering from severe psychopathological symptoms should be provided for para-athletes as well as for the general population

Training in psychosomatic medicine and psychotherapy for medical doctors in China: A field report

BackgroundThe high prevalence rates of mental disorders in China contrast a comparatively low care capacity from qualified trained medical doctors in the mental health field. The main objective of our cooperation project was to develop and implement advanced postgraduate training for medical doctors for their acquisition of knowledge, skills, and attitudes in the field of psychosomatic medicine and psychotherapy in China.MethodsMonitoring and evaluation as part of the advanced training in Beijing were conducted following the Kirkpatrick training approach using four levels of evaluation: reaction, learning, behavior and results. We performed a continuous course evaluation, assessed the respective learning goal attainment, conducted a pre-post evaluation of reasons and goals for participation in the training, and measured the treatment effects on the patient side.ResultsThe implementation of training standards in the field of psychosomatic medicine and psychotherapy for medical doctors and the transfer of didactic knowledge and skills for Chinese lecturers were achieved. A total of 142 mainly medical doctors attended the 2-year training. Ten medical doctors were trained as future teachers. All learning goals were reached. The content and didactics of the curriculum were rated with an overall grade of 1.23 (1 = very good to 5 = very bad). The highest rated elements were patient life interviews, orientation on clinical practice and communication skills training. The achievement of learning objectives for each block (depression, anxiety disorders, somatic symptom disorder, coping with physical diseases) was rated between 1 and 2 (1 = very well achieved to 5 = not achieved) for all items from participants’ perspectives. On the patient side (n = 415), emotional distress decreased and quality of life and the doctor–patient alliance improved significantly.DiscussionAdvanced training in psychosomatic medicine and psychotherapy was successfully implemented. The results of the evaluation show high participant satisfaction and the successful achievement of all learning objectives. A more detailed and extensive evaluation of the data, such as an analysis of the development of the participants as psychotherapists, is in preparation. The continuation of the training under Chinese guidance is guaranteed

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