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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

September 17, 2012
January 21, 2014
October 2012
September 2014   (final data collection date for primary outcome measure)
Zarit Caregiver Burden Interview (ZBI) [ Time Frame: 9 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01690117 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
German Adaptation of REACH II
German Adaptation of Resources to Enhance Alzheimer`s Caregiver Health

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Dementia
  • Family Caregiver
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
  • Experimental: DeREACH-program
    DeREACH-program
    Intervention: Behavioral: DeREACH-program
  • No Intervention: control group
    usual care

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
158
December 2014
September 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Clinical diagnosis of dementia for the patient
  • patients and caregivers living at home

Exclusion Criteria:

  • patient not able to give informed consent
Both
Not Provided
No
Contact: Martin Berwig, Dr. ++49 341 97 24465 Martin.Berwig@medizin.uni-leipzig.de
Germany
 
NCT01690117
IIA5-2512FSB552
No
Hermann-Josef Gertz, University of Leipzig
University of Leipzig
Not Provided
Principal Investigator: Hermann-Josef Gertz, Prof. Dr. Klinik und Poliklinik für Psychiatrie der Universität Leipzig
University of Leipzig
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP