Clinical trial NCT01690117: German Adaptation of REACH II
Official title: German Adaptation of Resources to Enhance Alzheimer's Caregiver Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Family Caregiver
Keywords: family caregiver
dementia
intervention
implementation
Lead sponsor: University of Leipzig
Sponsor class: OTHER
First posted: 2012-09-21
Enrollment: 92
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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.

Primary outcomes:
measure: Change From Baseline in Burden on the German Version of Zarit Caregiver Burden Interview (ZBI) (5-point Scale) at Month 6
timeFrame: baseline and month 6
measure: Change From Baseline in Burden on the German Version of Zarit Caregiver Burden Interview (ZBI) (5-point Scale) at Month 9
timeFrame: baseline and month 9
Secondary outcomes:
measure: Change From Baseline in Somatization on the Patient Health Questionaire - 15 Items (PHQ-15) - Module Somatization at Month 6
timeFrame: baseline and 6 month
measure: Change From Baseline in Somatization on the Patient Health Questionaire - 15 Items (PHQ-15) - Module Somatization at Month 9
timeFrame: baseline and month 9
measure: Change From Baseline in Mental Health on the Patient Health Questionnaire - 4 Items (PHQ-4) (4-point Scale) at Month 6
timeFrame: baseline and month 6
measure: Change From Baseline in Mental Health on the Patient Health Questionnaire - 4 Items (PHQ-4) (4-point Scale) at Month 9
timeFrame: baseline and month 9
measure: Change From Baseline in Social Support on the ENRICHED-Social-Support-Instrument (ESSI) (5-point Scale) at Month 6
timeFrame: baseline and month 6
measure: Change From Baseline in Social Support on the ENRICHED-Social-Support-Instrument (ESSI) (5-point Scale) at Month 9
timeFrame: baseline and month 9
measure: Change From Baseline in Psychological Quality of Life on the German Version of the Mental Component Summary of the General Health Questionaire Short Form 12 (SF-12) at Month 6
timeFrame: baseline and month 6
measure: Change From Baseline in Psychological Quality of Life on the German Version of the Mental Component Summary of the General Health Questionaire Short Form 12 (SF-12) at Month 9
timeFrame: baseline and month 9
measure: Change From Baseline in Physical Quality of Life on the German Version of the Physical Component Summary of the General Health Questionaire Short Form 12 (SF-12) at Month 6
timeFrame: baseline and month 6
measure: Change From Baseline in Physical Quality of Life on the German Version of the Physical Component Summary of the General Health Questionaire Short Form 12 (SF-12) at Month 9
timeFrame: baseline and month 9
measure: Change From Baseline in Frequency of Problem Behavior on a German Version of the Frequency Subscale of the Revised Memory and Behavior Problem Checklist (RMBPC) - (5-point Scale) at Month 6
timeFrame: baseline and month 6
measure: Change From Baseline in Frequency of Problem Behavior on a German Version of the Frequency Subscale of the Revised Memory and Behavior Problem Checklist (RMBPC) - (5-point Scale) at Month 9
timeFrame: baseline and month 9
measure: Change From Baseline in Strength of Reaction of Caregivers to Problem Behavior on a German Version of the Reaction Subscale of the Revised Memory and Behavior Problem Checklist (RMBPC) - (5-point Scale) at Month 6
timeFrame: baseline and month 6
measure: Change From Baseline in Strength of Reaction of Caregivers to Problem Behavior on a German Version of the Reaction Subscale of the Revised Memory and Behavior Problem Checklist (RMBPC) - (5-point Scale) at Month 9
timeFrame: baseline and month 9
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: Klinik und Poliklinik für Psychiatrie und Psychotherapie
state: Saxonia
Study officials:
affiliation: Klinik und Poliklinik für Psychiatrie der Universität Leipzig
name: Hermann-Josef Gertz, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.7326/0003-4819-145-10-200611210-00005.
citation: Berwig M, Heinrich S, Spahlholz J, Hallensleben N, Brahler E, Gertz HJ. Individualized support for informal caregivers of people with dementia - effectiveness of the German adaptation of REACH II. BMC Geriatr. 2017 Dec 12;17(1):286. doi: 10.1186/s12877-017-0678-y.
citation: Heinrich S, Berwig M, Simon A, Janichen J, Hallensleben N, Nickel W, Hinz A, Brahler E, Gertz HJ. German adaptation of the Resources for Enhancing Alzheimer's Caregiver Health II: study protocol of a single-centred, randomised controlled trial. BMC Geriatr. 2014 Feb 12;14:21. doi: 10.1186/1471-2318-14-21.