German Adaptation of REACH II

Dementia Clinical Trial

— DeREACH  

Official title:

German Adaptation of Resources to Enhance Alzheimer`s Caregiver Health

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01690117
• Other study ID #: IIA5-2512FSB552
• 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

• Dementia
• Family Caregiver

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

External Links

•   intervention manual and material of REACH II