Completed

GE-REACHGerman Adaptation of Resources to Enhance Alzheimer's Caregiver Health

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What is being tested

GE-REACH-program

Behavioral
Who is being recruted

Mental Disorders+3

+ Brain Diseases

+ Central Nervous System Diseases

See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: October 2012
See protocol details

Summary

Principal SponsorUniversity of Leipzig
Last updated: November 29, 2016
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Study start date: October 1, 2012

Actual date on which the first participant was enrolled.

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.

Principal SponsorUniversity of Leipzig
Last updated: November 29, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

92 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Mental DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersDementia

Criteria

Inclusion criteria age 21 years or older living with or sharing cooking facilities with the care recipient providing care for a relative with a medical diagnosed Alzheimer disease or related disorder, vascular dementia or behavior variant frontotemporal dementia for at least 4 hours per day for at least the past 6 months Exclusion criteria Involvment in another caregiver intervention actual psychiatric diagnosis of mental illness illness that would prevent 6 months of study participation forthcoming institutionalization of the person being cared. Other requirements were logistic, including having a telephone, planning to remain in the geographic area for at least 6 months, and competency in German.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
GE-REACH-program

Group II

No Intervention
usual care

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Klinik und Poliklinik für Psychiatrie und Psychotherapie

Leipzig, GermanyOpen Klinik und Poliklinik für Psychiatrie und Psychotherapie in Google Maps
CompletedOne Study Center