German Adaptation of REACH II (DeREACH)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by University of Leipzig
Sponsor:
Information provided by (Responsible Party):
Hermann-Josef Gertz, University of Leipzig
ClinicalTrials.gov Identifier:
NCT01690117
First received: September 17, 2012
Last updated: January 21, 2014
Last verified: January 2014
  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

Resource links provided by NLM:


Further study details as provided by University of Leipzig:

Primary Outcome Measures:
  • Zarit Caregiver Burden Interview (ZBI) [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01690117

Contacts
Contact: Martin Berwig, Dr. ++49 341 97 24465 Martin.Berwig@medizin.uni-leipzig.de

Locations
Germany
Klinik und Poliklinik für Psychiatrie und Psychotherapie Recruiting
Leipzig, Saxonia, Germany, 04103
Contact: Martin Berwig, Dr.    ++49 341 97 24465    Martin.Berwig@medizin.uni-leipzig.de   
Principal Investigator: Elmar Brähler, Prof. Dr.         
Sponsors and Collaborators
University of Leipzig
Investigators
Principal Investigator: Hermann-Josef Gertz, Prof. Dr. Klinik und Poliklinik für Psychiatrie der Universität Leipzig
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: January 21, 2014
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
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on October 22, 2014