German Adaptation of REACH II (DeREACH)
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Purpose
The purpose of the present study is to adapt, to implement and to evaluate an support program for family caregivers of patients suffering from Alzheimers`Disease (AD). The intervention was comprehensive developed and successful evaluated in the USA and is called Resources to Enhance Alzheimers´Caregiver Health -second step (REACH II). To test the effectiveness of this German adaptation of REACH II the present implementation study is designed as randomized and controlled trial. Primary outcome is reducing family caregiver burden.
| Condition | Intervention |
|---|---|
|
Dementia Family Caregiver |
Behavioral: DeREACH-program |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | German Adaptation of Resources to Enhance Alzheimer`s Caregiver Health |
- Zarit Caregiver Burden Interview (ZBI) [ Time Frame: 9 months ] [ Designated as safety issue: No ]
- Patient Health Questionnaire (PHQ) [ Time Frame: 9 months ] [ Designated as safety issue: No ]
- ENRICHED-Social-Support-Instrument (ESSI) [ Time Frame: 9 months ] [ Designated as safety issue: No ]
- SF 12 Health Survey [ Time Frame: 9 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 158 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | September 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: DeREACH-program
DeREACH-program
|
Behavioral: DeREACH-program
The intervention program "Resources to Enhance Alzheimer`s Caregivers Health -second step" (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers
|
|
No Intervention: control group
usual care
|
Detailed Description:
Caring for elderly people with dementia imposes a heavy strain on care providers like family caregivers and puts them at risk of psychological and physical morbidity. A variety of psychosocial interventions have been developed which aim at improving caregiver emotional and physical health. These interventions differ in terms of treatment delivery (individual or group format) and content (education, symptom appraisal, problem solving, skill building, stress management or behavior modification). Systematic reviews and meta analyses have concluded that individualized programs have a greater impact than group interventions, and problem solving or behavior modification strategies are superior to education alone. Structured multi-component interventions may also reduce the risk of patients home admissions.
The intervention program "Resources to Enhance Alzheimer`s Caregivers Health -second step" (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers and was successfully evaluated in a multisite, randomized and controlled trial in the USA. The overall objectives of REACH II are to identify and reduce modificable risk factors to enhance the well-being of the caregivers and to enhance the quality of care. It takes place at caregivers home and focuses on 5 domains that are important to caregivers: reducing depression, decreasing burden, improving self care, enhancing social support, and managing problem behaviours.
Since there is a lack of effective treatment programs for family caregivers of demented persons in the German Health system respectively care system the purpose of the present study is to adapt and to implement REACH II to the care system conditions of a medium-sized East German town (Leipzig). To test the effects of this adapted intervention program the present study is design as unisite, randomized and controlled trail. Primary outcome is reducing family caregiver burden.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Clinical diagnosis of dementia for the patient
- patients and caregivers living at home
Exclusion Criteria:
- patient not able to give informed consent
Contacts and Locations| Contact: Martin Berwig, Dr. | ++49 341 97 24465 | Martin.Berwig@medizin.uni-leipzig.de |
| Germany | |
| Klinik und Poliklinik für Psychiatrie und Psychotherapie | Not yet recruiting |
| Leipzig, Sachsen, Germany, 04103 | |
| Contact: Martin Berwig, Dr. ++49 341 97 24465 Martin.Berwig@medizin.uni-leipzig.de | |
| Principal Investigator: Elmar Brähler, Prof. Dr. | |
| Principal Investigator: | Hermann-Josef Gertz, Prof. Dr. | Klinik und Poliklinik für Psychiatrie der Universität Leipzig |
More Information
Additional Information:
Publications:
| Responsible Party: | Hermann-Josef Gertz, Prof. Dr., University of Leipzig |
| ClinicalTrials.gov Identifier: | NCT01690117 History of Changes |
| Other Study ID Numbers: | IIA5-2512FSB552 |
| Study First Received: | September 17, 2012 |
| Last Updated: | September 20, 2012 |
| Health Authority: | Germany: Ministry of Health |
Keywords provided by University of Leipzig:
|
family caregiver dementia intervention implementation |
Additional relevant MeSH terms:
|
Dementia Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders |
ClinicalTrials.gov processed this record on June 18, 2013