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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01690117
Other study ID # IIA5-2512FSB552
Secondary ID
Status Recruiting
Phase N/A
First received September 17, 2012
Last updated January 21, 2014
Start date October 2012
Est. completion date December 2014

Study information

Verified date January 2014
Source University of Leipzig
Contact Martin Berwig, Dr.
Phone ++49 341 97 24465
Email Martin.Berwig@medizin.uni-leipzig.de
Is FDA regulated No
Health authority Germany: Ministry of Health
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 158
Est. completion date December 2014
Est. primary completion date September 2014
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Clinical diagnosis of dementia for the patient

- patients and caregivers living at home

Exclusion Criteria:

- patient not able to give informed consent

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Germany Klinik und Poliklinik für Psychiatrie und Psychotherapie Leipzig Saxonia

Sponsors (1)

Lead Sponsor Collaborator
University of Leipzig

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Belle SH, Burgio L, Burns R, Coon D, Czaja SJ, Gallagher-Thompson D, Gitlin LN, Klinger J, Koepke KM, Lee CC, Martindale-Adams J, Nichols L, Schulz R, Stahl S, Stevens A, Winter L, Zhang S; Resources for Enhancing Alzheimer's Caregiver Health (REACH) II Investigators. Enhancing the quality of life of dementia caregivers from different ethnic or racial groups: a randomized, controlled trial. Ann Intern Med. 2006 Nov 21;145(10):727-38. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Zarit Caregiver Burden Interview (ZBI) 9 months No
Secondary Patient Health Questionnaire (PHQ) 9 months No
Secondary ENRICHED-Social-Support-Instrument (ESSI) 9 months No
Secondary SF 12 Health Survey 9 months No
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