Laying the foundation for an ICF core set for community dwelling older adults in primary care: an expert survey.

BACKGROUND: A holistic biopsychosocial model focused on functioning in individual contexts (environment, task) is better suited to meet the needs of older patients than disease only based models. The International Classification of Functioning, Disability and Health (ICF) is the official standard for describing functional health. As the ICF is too detailed to be used in practice, brief core sets have been developed. OBJECTIVE: This study aimed to identify relevant aspects of functioning for older primary care patients from the perspective of healthcare professionals in Germany. MATERIAL AND METHODS: An internet-based cross-sectional expert survey was conducted in preparation for the development of an ICF core set for community-dwelling patients aged 75 years and older. Open-ended questions to identify the most important aspects of functioning and disability in old age were used. Responses were analyzed based on a content analysis approach to identify relevant concepts in the care of the target population. These concepts were then linked to ICF categories according to established linking rules. RESULTS: A total of 63 experts participated in this survey. Across all responses, 2240 meaningful concepts were identified. A total of 75 ICF categories (4 first level categories, 67 second level categories, 4 code combinations) were identified by at least 5% of respondents and will thus be considered as candidate categories for the final ICF core set. Most of concepts were associated with the environmental factors component. The most frequently identified categories were immediate family and family relationships. CONCLUSION: This survey provides a list of relevant ICF categories from the experts' perspective and together with other preparatory studies will be used for developing an ICF core set for community-dwelling older adults in primary care.

A German climbing study on depression: a bouldering psychotherapeutic group intervention in outpatients compared with state-of-the-art cognitive behavioural group therapy and physical activation - study protocol for a multicentre randomised controlled trial.

BACKGROUND: Besides classical approaches for treating depression, physical activity has been demonstrated to be an effective option. Bouldering psychotherapy (BPT) combines psychotherapeutic interventions with action-oriented elements from the field of climbing. The aim of this study is to investigate the effectiveness of BPT compared with a home-based exercise program (EP - active control group, superiority trial) and state-of-the-art cognitive behavioural therapy (CBT - non-inferiority trial). METHODS: The study is being conducted as a multicentre randomised controlled intervention trial at three locations in Germany. Participants are being randomised into three groups: BPT, CBT, or EP, each with a 10-week treatment phase. A power analysis indicated that about 240 people should initially be included. The primary outcome of the study is the Montgomery and Asberg Depression Rating Scale (MADRS) directly after the intervention. Additional measurement points are located three, six, and 12 months after the end of the intervention. The data are being collected via computer-assisted telephone interviews. Statistical analyses comprise regression analyses to test for the superiority of BPT over EP. To test for the non-inferiority of BPT and CBT, a non-inferiority margin of 1.9 points in the Patient Health Questionnaire (PHQ-9) and two non-inferiority margins for the MADRS (half of the two smallest Cohen's d values from the current meta-analyses) was predefined. The mean difference between CBT and EP is being used as a supplementary equivalence margin. DISCUSSION: This is the first study to investigate the effect of a bouldering psychotherapy (BPT) on outpatients' depressive symptoms compared with mere physical activity (superiority analysis) and state-of-the-art cognitive behavioural therapy (CBT, non-inferiority analysis). Methodological strengths of the study are the elaborated, multicentred, randomised, controlled design. Assessors are blinded with regard to group allocation which leads to high objectivity. The study is conducted in a naturalistic setting, which leads to high external validity. Methodological limitations might be the clinical heterogeneity of the sample, which may dilute the intervention effects. TRIAL REGISTRATION: ISRCTN12457760 (Registration date: 26 July 2017, retrospectively registered).

The Erlangen test of activities of daily living in persons with mild dementia or mild cognitive impairment (ETAM) - an extended validation.

BACKGROUND: The ability to perform activities of daily living (ADLs) is a central marker in the diagnosis and progression of the dementia syndrome. ADLs can be identified as basic ADLs (BADLs), which are fairly easy to perform, or instrumental ADLs (IADLs), which involve more complex activities. Presently, the only performance-based assessment of IADL capabilities in persons with cognitive impairment is the Erlangen Test of Activities of Daily Living in Persons with Mild Dementia or Mild Cognitive Impairment (ETAM). The aim of the present study was to revalidate the ETAM in persons with mild cognitive impairment (MCI) or mild dementia and to analyze its application to persons with moderate dementia. METHODS: We used baseline data from a cluster randomized controlled trial involving a sample of 443 users of 34 day-care centers in Germany. We analyzed groups of persons with MCI, mild dementia, and moderate dementia, categorized on the basis of the Mini-Mental State Examination (MMSE) and the Montreal Cognitive Assessment (MoCA). An item analysis was performed, and new discriminant validities were calculated. We computed a confirmatory factor analysis (CFA) to examine the postulated theoretical model of the ETAM with all six items loading on a single IADL factor. This was the first time that the ETAM's sensitivity to change was analyzed after a time period of 6 months. RESULTS: The overall sample scored on average 17.3 points (SD = 7.2) on the ETAM (range: 0-30 points). Persons with MCI scored on average 23.2 points, persons with mild dementia scored 18.4 points, and persons with moderate dementia scored 12.9 points, p < .001 (ANOVA). The item analysis yielded good difficulty indices and discrimination powers. The CFA indicated a good fit between the model and the observed data. After 6 months, both the ETAM score at baseline and the change in MMSE score (t0-t1) were significant predictors of the ETAM score at t1. CONCLUSIONS: The ETAM is a valid and reliable instrument for assessing IADL capabilities in persons with MCI or mild dementia. It is sensitive to changes in cognitive abilities. The test parameters confirm its application to persons with moderate dementia. TRIAL REGISTRATION: Identifier: ISRCTN16412551 (Registration date: 30 July 2014, registered retrospectively).

The German day-care study: multicomponent non-drug therapy for people with cognitive impairment in day-care centres supplemented with caregiver counselling (DeTaMAKS) - study protocol of a cluster-randomised controlled trial.

BACKGROUND: It is the wish of both people with cognitive impairment and their informal caregivers for the impaired person to live at home for as long as possible. This is also in line with economic arguments about health. The existing structure of day-care services for the elderly can be used to achieve this. Due to the current lack of empirical evidence in this field, most day-care centres do not offer a scientifically evaluated, structured intervention, but instead offer a mixture of individual activities whose efficacy has not yet been established. Informal caregivers of people with dementia use day-care centres primarily to relieve themselves of their care tasks and as a support service. METHODS/DESIGN: The present study therefore investigates the effectiveness of a combination of a multicomponent activation therapy for people with mild cognitive impairment (MCI) or mild to moderate dementia at day-care centres and a brief telephone intervention for their informal caregivers. The study is conducted as a cluster-randomised intervention trial at 34 day-care centres in Germany with a 6-month treatment phase. The centres in the waitlist control group provide "care as usual". A power analysis indicated that 346 people should initially be included in the study. The primary endpoints of the study include the ability to perform activities of daily living (ADL) and cognitive capacities on the side of the day-care centre users and the subjectively perceived burden and well-being of the informal caregivers. The total duration of the study is 3 years, during which data are collected both by the psychometric testing of the people with cognitive impairment and by telephone interviews with informal caregivers. DISCUSSION: The project has three distinctive quality features. First, it is embedded in real care situations since the day-care services have already been established for this target group. Second, due to the large number of cases and the fact that the participating day-care centres are spread across the entire country, the results can be expected to be generalisable. Third, the interventions can be assumed to be implementable as they required only a one-day training event for the staff already working at the centres. TRIAL REGISTRATION: ISRCTN16412551 (Registration date: 30 July 2014, registered retrospectively).

Validation of the Erlangen Test of Activities of Daily Living in Persons with Mild Dementia or Mild Cognitive Impairment (ETAM).

BACKGROUND: There are currently no valid, fast, and easy-to-administer performance tests that are designed to assess the capacities to perform activities of daily living in persons with mild dementia and mild cognitive impairment (MCI). However, such measures are urgently needed for determining individual support needs as well as the efficacy of interventions. The aim of the present study was therefore to validate the Erlangen Test of Activities of Daily Living in Persons with Mild Dementia and Mild Cognitive Impairment (ETAM), a performance test that is based on the International Classification of Functioning and Health (ICF), which assesses the relevant domains of living in older adults with MCI and mild dementia who live independently. METHODS: The 10 ICF-based items on the research version of the ETAM were tested in a final sample of 81 persons with MCI or mild dementia. The items were selected for the final version in accordance with 6 criteria: 1) all domains must be represented and have equal weight, 2) all items must load on the same factor, 3) item difficulties and item discriminatory powers, 4) convergent validity (Bayer Activities of Daily Living Scale [B-ADL]) and discriminant validity (Mini Mental State Examination [MMSE], Geriatric Depression Scale 15 [GDS-15]), 5) inter-rater reliabilities of the individual items, 6) as little material as possible. Retest reliability was also examined. Cohen's ds were calculated to determine the magnitudes of the differences in ETAM scores between participants diagnosed with different grades of severity of cognitive impairment. RESULTS: The final version of the ETAM consists of 6 items that cover the five ICF domains communication, mobility, self-care, domestic life (assessed by two 3-point items), and major life areas (specifically, the economic life sub-category) and load on a single factor. The maximum achievable score is 30 points (6 points per domain). The average administration time was 35 min, 19 of which were needed for pure item performance. The internal consistency was α = .71. The three-week test-retest reliability was r = .78, and the inter-rater reliability was r = .97. The ETAM also provided satisfactory discrimination between healthy individuals and persons with MCI or mild dementia as well as between persons with mild and moderate dementia. CONCLUSIONS: The 6-item final version of the ETAM shows satisfactory psychometric characteristics and can be administered quickly. It is therefore suitable for use in both clinical practice and research.

Indoor rock climbing (bouldering) as a new treatment for depression: study design of a waitlist-controlled randomized group pilot study and the first results.

BACKGROUND: Depression is one of the most common diseases in industrialised nations. Physical activity is regarded as an important part of therapeutic intervention. Rock climbing or bouldering (rock climbing to moderate heights without rope) comprises many aspects that are considered useful, but until now, there has been hardly any research on the effects of a bouldering group intervention on people with depression. The purpose of this controlled pilot study was twofold: first, to develop a manual for an eight-week interventional program that integrates psychotherapeutic interventions in a bouldering group setting and second, to assess the effects of a bouldering intervention on people with depression. METHODS: The intervention took place once a week for three hours across a period of eight weeks. Participants were randomly assigned to the two groups (intervention vs. waitlist). The intervention group began the bouldering therapy immediately after a baseline measurement was taken; the waitlist participants began after an eight-week period of treatment as usual. On four measurement dates at eight-week intervals, participants completed the Beck Depression Inventory II (BDI-II), the symptom checklist-90-R (SCL-90), the questionnaire on resources and self-management skills (FERUS), and the attention test d2-R. A total of 47 participants completed the study, and the data were analysed with descriptive statistics. Cohen's d was calculated as a measure of the effect size. For the primary hypothesis, a regression analysis and the Number Needed to Treat (NNT) (improvement of at least 6 points on the BDI-II) were calculated. RESULTS: After eight weeks of intervention, results indicated positive effects on the measures of depression (primary hypothesis: BDI-II: Cohen's d = 0.77), this was supported by the regression analysis with "group" as the only significant predictor of a change in depression (p = .007). The NNT was four. CONCLUSIONS: These findings provide the first evidence that therapeutic bouldering may offer an effective treatment for depression. Further research is required. TRIAL REGISTRATION: Current controlled trials, ISRCTN17623318 , registered on July 15(th) 2015.

Individualised computerised cognitive training for community-dwelling people with mild cognitive impairment: study protocol of a completely virtual, randomised, controlled trial.

BACKGROUND: People with mild cognitive impairment (MCI) are at increased risk of converting to dementia. Cognitive training can improve the cognitive abilities of people with MCI. Computerised cognitive training (CCT) offers several advantages over traditional paper-and-pencil cognitive training and has the potential to be more individualised by matching task difficulty with individual performance. Recent systematic reviews have reported promising effects of CCT on improving the cognitive capacities of people with MCI. However, the quality of existing studies has been limited, and it is still unclear whether CCT can influence the progression to dementia. We developed an 'individualised' CCT (MAKSCog) specialised for people with MCI that automatically matches task difficulty with individual performance and an active control training ('basic' CCT). The aims of the present study are (a) to evaluate MAKSCog and (b) to investigate whether it can be applied to maintain the cognitive abilities of people with MCI. METHODS: The present study investigates the effects of CCT on cognition in a randomised controlled intervention study in Germany. Participants are community-dwelling people with a psychometric diagnosis of MCI based on the Montreal Cognitive Assessment (MoCA) and Mini-Mental Status Test (MMSE). Screening and baseline testing are conducted via a videoconferencing assessment and telephone. Participants are randomly allocated. The treatment phase is 6 months with an open phase in which participants can freely decide to continue to use the CCTs. Additionally, both CCTs contain a monthly computerised cognitive assessment that measures different cognitive abilities: information processing speed, memory span, short term memory, and logical reasoning. DISCUSSION: This is the first study to investigate the effect of MAKSCog, an individualised CCT, specifically developed for people with different subtypes of MCI. A methodological strength is the double-blind, randomised, controlled design and the use of basic CCT as an active control group. The study is conducted entirely virtually with valid telehealth assessments for cognitive function. Methodological limitations might include a restriction to participants who feel comfortable with the use of technology and who own a computer, laptop, or tablet. TRIAL REGISTRATION: ISRCTN ISRCTN14437015 . Prospectively registered on 27 February 2020.

Computerised cognitive training tools and online nutritional group counselling for people with mild cognitive impairment: study protocol of a completely digital, randomised, controlled trial.

INTRODUCTION: People with mild cognitive impairment (MCI) are at increased risk of decreasing cognitive functioning. Computerised cognitive training (CCT) and nutrition have been shown to improve the cognitive capacities of people with MCI. For each variable, we developed two kinds of interventions specialised for people with MCI (CCT: 'individualised' CCT; nutrition: a whole-food, plant-based diet). Additionally, there are two kinds of active control measures (CCT: 'basic' CCT; nutrition: a healthy diet following the current guidelines of the German Nutrition Society). The aim of this study is to investigate the effects of the two interventions on cognition in people with MCI in a 2×2 randomised controlled trial with German participants. METHODS AND ANALYSIS: Participants will be community-dwelling individuals with a psychometric diagnosis of MCI based on the Montreal Cognitive Assessment (MoCA) and Mini-Mental State Examination. With N=200, effects with an effect size of f≥0.24 (comparable to Cohen's d≥0.48) can be detected. Screening, baseline, t6 and t12 testing will be conducted via a videoconferencing assessment, telephone, and online survey. Participants will be randomly allocated to one of four groups and will receive a combination of CCT and online nutritional counselling. The CCT can be carried out independently at home on a computer, laptop, or tablet. Nutrition counselling includes 12 online group sessions every fortnight for 1.5 hours. The treatment phase is 6 months with follow-ups after six and 12 months after baseline. ETHICS AND DISSEMINATION: All procedures were approved by the Friedrich-Alexander-Universität Erlangen-Nürnberg Ethics Committee (Ref. 21-318-1-B). Written informed consent will be obtained from all participants. Results will be published in peer-reviewed scientific journals, conference presentations. TRIAL REGISTRATION NUMBER: ISRCTN10560738.

Laying the foundation for a primary care core set of the International Classification of Functioning, Disability and Health (ICF) for community-dwelling older adults: A qualitative study.

OBJECTIVE: To explore relevant areas of functioning from the perspective of community-dwelling adults aged 75 years and over, in order to develop a Core Set of the International Classification of Functioning, Disability and Health (ICF) for community-dwelling older adults for use in primary care. DESIGN: Qualitative study using semi-structured interviews and focus groups. PARTICIPANTS: A total of 27 community-dwelling older adults participated in the interviews and 24 of them in the focus groups. METHODS: Following the proposed methodology of the ICF Research Branch, this is 1 of 4 preparatory studies in the Core Set development process. Within the transcripts, concepts of functioning were identified, based on Mayring's qualitative content analysis using deductive category assignment with the ICF being the category system. RESULTS: Overall 6,667 concepts were identified. Most were linked to the Activities and Participation component. The most frequently identified categories were "recreation and leisure" and "family relationships". CONCLUSION: Categories from all ICF chapters were identified, demonstrating the complexity and multidimensionality of the ageing process, with a special emphasis on the component Activities and Participation. This qualitative study provides a list of relevant categories from the perspective of community--dwelling elderly people, which will be used to develop a Core Set for older primary care patients.

Laying the foundation for a Core Set of the International Classification of Functioning, Disability and Health for community-dwelling older adults in primary care: relevant categories of their functioning from the research perspective, a scoping review.

OBJECTIVES: The objective of this study was to find relevant concepts of functioning in community-dwelling older adults within frequently used assessment instruments published in the scientific literature. This was part of a larger project to develop an International Classification of Functioning, Disability and Health (ICF) Core Set for use in primary care. DESIGN: A scoping review was conducted. Articles dealing with functioning in older adults were searched and assessed for eligibility. The study population included community-dwelling adults (≥75 years) without dementia, living in high-resource countries. Relevant concepts were extracted from assessment instruments and linked to the ICF using standardised linking rules. Finally, a frequency analysis was conducted. SETTING: Home, primary care. PARTICIPANTS: Community-dwelling adults aged 75 years and above. RESULTS: From 5060 identified publications, 68 were included and 30 assessment instruments extracted. Overall, 1182 concepts were retrieved. Most were linked to the 'activities and participation' component. The most frequently identified categories were 'memory functions', 'dressing' and 'changing basic body position'. CONCLUSIONS: This review provides a list of relevant ICF categories from the research perspective that will be used for developing an ICF Core Set for older primary care patients. TRIAL REGISTRATION NUMBERS: PROSPERO (CRD42017067784), Versorgungsforschung Deutschland Datenbank (VfD_17_003833) and ClinicalTrials.gov (NCT03384732).

Laying the foundation for an International Classification of Functioning, Disability and Health Core Set for community-dwelling elderly adults in primary care: the clinical perspective identified in a cross-sectional study.

OBJECTIVES: Having more information about the biopsychosocial functioning of their geriatric patients might help physicians better balance medical interventions according to patients' needs. For this reason, we aimed to develop an easy-to-handle International Classification of Functioning, Disability and Health (ICF) Core Set for community-dwelling geriatric patients aged 75 and older in primary care. In this empirical study, we describe the functioning and health of community-dwelling patients aged 75 and older in primary care in Germany and identify the most common problems encountered by these individuals when using the ICF. DESIGN: In this exploratory, cross-sectional study, a health professional conducted semi-structured interviews. SETTING: Community-dwelling older adults aged 75 and older in Germany. PARTICIPANTS: 65 participants (mean age=80.2, SD=3.6). OUTCOME MEASURES: Extended ICF Checklist V.2.1a, patients prioritised chapters of the 'activities and participation' component. RESULTS: The three most common impairments for 'body functions' were visual system functions (ICF-code b210; 89%), blood pressure functions (b420; 80%) and sensations associated with hearing and vestibular functions (b240; 59%). For 'body structures', they were eyes, ears and related structures (s2; 81%), structure of mouth (s320; 74%) and structures related to the digestive, metabolic and endocrine systems (s5; 49%). For the 'activities and participation' component, adequate aids compensated for activity limitations to a certain degree. Still, after having adequate aids, the category in which the participants had the most difficulty was walking (d450; 35%). Participants rated the 'mobility' chapter as the most important of all chapters. 'Environmental factors' were facilitators of participants' functioning. CONCLUSIONS: This empirical study provides a list of ICF categories relevant to older adults from the clinical perspective. Along with lists from the other three preparatory studies, it will form the basis for the development of an ICF Core Set for community-dwelling older adults in primary care. TRIAL REGISTRATION DETAILS: The trial is registered in ClinicalTrials.gov (NCT03384732).

Long-term effects of bouldering psychotherapy on depression: benefits can be maintained across a 12-month follow-up.

BACKGROUND: Previous studies have identified positive effects of Bouldering Psychotherapy (BPT) on symptoms of depression. The aim of the present study was to investigate the short- and long-term effects of BPT on 97 participants with depression. METHODS: BPT took place once a week over a period of 8 weeks. In a waitlist control group design, participants were assessed at baseline and after 8 weeks (end of BPT for the intervention group; start of BPT for the waitlist group), 16 weeks, and 12 months. The main outcome was severity of depression measured with the Beck Depression Inventory II (BDI-II). RESULTS: Depression scores dropped by 7.21 on the BDI-II during the first intervention period with a Cohen's d of 0.59. A regression analysis at t1 showed that group allocation (p < .001) was the only significant predictor besides the baseline depression score (p < .001). A 12-month (after t0) follow-up measurement showed that the decrease in depression severity remained stable during that time, with values of d = 0.37 for the intervention group and d = 0.43 for the waitlist group. LIMITATIONS: Limitations of the study are the assessment of symptoms via only self-report, the lack of a control group during follow-up, and different durations of the follow-up period in the two groups. CONCLUSION: Our results augment the findings of previous studies regarding the short-term effects of BPT and provide initial evidence that the positive effects of BPT on depression severity can be maintained across a period of 12 months.

Bouldering psychotherapy reduces depressive symptoms even when general physical activity is controlled for: A randomized controlled trial.

BACKGROUND: Bouldering psychotherapy (BPT) combines psychotherapeutic elements with physical activity (PA). It might be effective for reducing symptoms of depression, but so far, no study has assessed individuals' levels of PA to control for whether positive effects on depression can also be found when adjusting for participants' levels of PA. This is important because PA itself has been proven effective in reducing depression and therefore might be an important variable to account for - especially in therapies using sport as one therapeutic mechanism. METHODS: Using a waitlist control group design, outpatients with depression were assessed at baseline and after eight, 16, and 24 weeks. The intervention group took part in an eight-week bouldering psychotherapy which met once a week for three hours. Self-report measures before and after the intervention included the Symptom Checklist-90-R (SCL-90-R), the Beck Depression Inventory (BDI-II), and the questionnaire on resources and self-management skills (FERUS). PA was assessed during the first 16-week period via FitBit Zip accelerometers. RESULTS: Altogether, 47 complete cases (20 men and 27 women) were included in the final analyses. Depression scores dropped by up to 6.74 (CI 2.80-10.67) points on the SCL-90-R depression scale and by up to 8.26 (CI 4.21-12.31) points on the BDI-II during the BPT intervention, the control group remained stable (SCL-90-R Cohen's d = 0.60; BDI-II: Cohen's d = .50). All Participants accrued an average of 6,515 steps per day, which is considered "low-active." Participants of the BPT intervention were significantly more likely to reduce their depressive symptoms (p = .025) than participants of the control group, even when PA was controlled for in a regression analysis. LIMITATIONS: Limitations of the study are the relatively small number of patients and the assessment of outcome scores via self-report. CONCLUSIONS: This study provides evidence that short-term BPT can be effective for reducing symptoms of depression even if controlled for other therapeutically active confounders including antidepressant medication, psychotherapy and general level of PA.

Laying the foundation for a core set of the International Classification of Functioning, Disability and Health for community-dwelling adults aged 75 years and above in general practice: a study protocol.

INTRODUCTION: With the medical focus on disease, the problem of overdiagnosis inevitably increases with ageing. Considering the functional health of patients might help to discriminate between necessary and unnecessary medicine. The International Classification of Functioning, Disability and Health (ICF) is an internationally recognised tool for describing functional health. However, it is too detailed to be used in primary care practices. Consequently, the aim of this study is to identify relevant codes for an ICF core set for community-dwelling older adults (75 years and above) in primary care. METHODS AND ANALYSIS: The study will follow the methodology proposed by the ICF Research Branch to identify relevant concepts from different perspectives: (1) Research perspective: A systematic review of studies focusing on functional health in old age will be conducted in different databases. Relevant concepts will be extracted from the publications. (2) Patients' perspective: Relevant areas of functioning and disability will be identified conducting qualitative interviews and focus groups with community-dwelling older persons. The interviews will be transcribed verbatim and analysed using the documentary method of interpretation. (3) Experts' perspective: An online survey with open-ended questions will be conducted. Answers will be analysed using the qualitative content analysis of Mayring. (4) Clinical perspective: A cross-sectional empirical study will be performed to assess the health status of community-dwelling older adults using the extended ICF checklist and other measurement tools.Relevant concepts identified in each study will be linked to ICF categories resulting in four preliminary core sets. ETHICS AND DISSEMINATION: Ethical approval for the study was obtained (90_17B). All participants will provide written informed consent. Data will be pseudonymised for analysis. Results will be disseminated by conference presentations and journal publications. TRIAL REGISTRATION NUMBER: Projektdatenbank Versorgungsforschung Deutschland: VfD_17_003833,Clinicaltrials.gov: NCT03384732 and PROSPERO: CRD42017067784.