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German Adaptation of REACH II (GE-REACH)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hermann-Josef Gertz, University of Leipzig
ClinicalTrials.gov Identifier:
NCT01690117
First received: September 17, 2012
Last updated: October 5, 2016
Last verified: October 2016

September 17, 2012
October 5, 2016
October 2012
January 2015   (final data collection date for primary outcome measure)
  • Change From Baseline in Burden on the German Version of Zarit Caregiver Burden Interview (ZBI) (5-point Scale) at Month 6 [ Time Frame: baseline and month 6 ] [ Designated as safety issue: No ]
    The ZBI is a validated , self-reported instrument assessing burden of caregivers of people with dementia over a undefined period of time. Possible scores range from 0 (no burden) to 88 (highest possible burden). Change = (month 6 - baseline score).
  • Change From Baseline in Burden on the German Version of Zarit Caregiver Burden Interview (ZBI) (5-point Scale) at Month 9 [ Time Frame: baseline and month 9 ] [ Designated as safety issue: No ]
    The ZBI is a validated , self-reported instrument assessing burden of caregivers of people with dementia over a undefined period of time. Possible scores range from 0 (no burden) to 88 (highest possible burden). Change = (month 9 - baseline score).
Zarit Caregiver Burden Interview (ZBI) [ Time Frame: 9 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01690117 on ClinicalTrials.gov Archive Site
  • Change From Baseline in Somatization on the Patient Health Questionaire - 15 Items (PHQ-15) - Module Somatization at Month 6 [ Time Frame: baseline and 6 month ] [ Designated as safety issue: No ]
    PHQ-15 is a validated, self-reported instrument assessing somatization over the last 4-weeks time period. Possible scores range from 0 (no somatization) to 30 (most possible somatization). Change = (Month 6 Score - Baseline score)
  • Change From Baseline in Somatization on the Patient Health Questionaire - 15 Items (PHQ-15) - Module Somatization at Month 9 [ Time Frame: baseline and month 9 ] [ Designated as safety issue: No ]
    PHQ-15 is a validated, self-reported instrument assessing somatization over the last 4-weeks time period. Possible scores range from 0 (no somatization) to 30 (most possible somatization). Change = (Month 9 Score - Baseline score)
  • Change From Baseline in Mental Health on the Patient Health Questionnaire - 4 Items (PHQ-4) (4-point Scale) at Month 6 [ Time Frame: baseline and month 6 ] [ Designated as safety issue: No ]
    PHQ-4 is a validated, self-reported Instrument assessing mental health over a 2 - week period. Possible scores range from 0 (not ill) to 18 (worst possible mental illness). Change = (Month 6 Score - Baseline score)
  • Change From Baseline in Mental Health on the Patient Health Questionnaire - 4 Items (PHQ-4) (4-point Scale) at Month 9 [ Time Frame: baseline and month 9 ] [ Designated as safety issue: No ]
    PHQ-4 is a validated, self-reported Instrument assessing mental health over a 2 - week period. Possible scores range from 0 (not mental ill) to 18 (worst possible mental illness). Change = (Month 9 Score - Baseline score)
  • Change From Baseline in Social Support on the ENRICHED-Social-Support-Instrument (ESSI) (5-point Scale) at Month 6 [ Time Frame: baseline and month 6 ] [ Designated as safety issue: No ]
    ESSI is a validated, self-reported instrument assessing perceived social support of the caregivers over a undefined period of time. Possible scores range from 1 (no social support) to 25 (most possible social support). Change = (month 6 score - Baseline score)
  • Change From Baseline in Social Support on the ENRICHED-Social-Support-Instrument (ESSI) (5-point Scale) at Month 9 [ Time Frame: baseline and month 9 ] [ Designated as safety issue: No ]
    ESSI is a validated, self-reported instrument assessing perceived social support of the caregivers over a undefined period of time. Possible scores range from 1 (no social support) to 25 (most possible social support). Change = (month 9 score - Baseline score)
  • 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 [ Time Frame: baseline and month 6 ] [ Designated as safety issue: No ]
    SF-12 - mental component is a validated, self-reported instrument assessing psychological quality of live of the caregivers over the last four weeks time period. Possible scores range from 0 (lowest level of health) and 100 (highest level of health). Change = (Month 6 Score - Baseline score)
  • 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 [ Time Frame: baseline and month 9 ] [ Designated as safety issue: No ]
    SF-12 is a validated, self-reported instrument assessing psychological and physical quality of live of the caregivers over the last four weeks time period. Possible scores range from 0 (lowest level of health) and 100 (highest level of health). Change = (Month 9 Score - Baseline score)
  • 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 [ Time Frame: baseline and month 6 ] [ Designated as safety issue: No ]
    SF-12 is a validated, self-reported instrument assessing psychological and physical quality of live of the caregivers over the last four weeks time period. Possible scores range from 0 (lowest level of health) and 100 (highest level of health). Change = (Month 6 Score - Baseline score)
  • 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 [ Time Frame: baseline and month 9 ] [ Designated as safety issue: No ]
    SF-12 is a validated, self-reported instrument assessing psychological and physical quality of live of the caregivers over the last four weeks time period. Possible scores range from 0 (lowest level of health) and 100 (highest level of health). Change = (Month 9 Score - Baseline score)
  • 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 [ Time Frame: baseline and month 6 ] [ Designated as safety issue: No ]
    RMBPC frequency subscale is a validated, proxy-reported instrument assessing the frequency of problem behavior of cognitively impaired persons over the last week time period. Possible scores range from 0 (never occured) and 96 (extremely often). Change = (Month 6 Score - Baseline score)
  • 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 [ Time Frame: baseline and month 9 ] [ Designated as safety issue: No ]
    The frequency subscale of the RMBPC is a validated proxy-reported instrument assessing the frequency of problem behavior of cognitively impaired persons over the last week time period. Possible scores range from 0 (never occured) and 96 (extremely often). Change = (Month 9 Score - Baseline score)
  • 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 [ Time Frame: baseline and month 6 ] [ Designated as safety issue: No ]
    RMBPC reaction subscale is a validated self-reported instrument assessing the strength of reaction of caregivers to problem behavior of cognitively impaired persons over the last week time period. Possible scores range from 0 (no reaction) and 96 (extremely strong reaction). Change = (Month 6 Score - Baseline score)
  • 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 [ Time Frame: baseline and month 9 ] [ Designated as safety issue: No ]
    RMBPC reaction subscale is a validated self-reported instrument assessing the strength of reaction of caregivers to problem behavior of cognitively impaired persons over the last week time period. Possible scores range from 0 (no reaction) and 96 (extremely strong reaction). Change = (Month 9 Score - Baseline score)
  • 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 ]
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: GE-REACH-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: GE-REACH-program
    GE-REACH-program
    Intervention: Behavioral: GE-REACH-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.
 
Completed
92
January 2015
January 2015   (final data collection date for primary outcome measure)

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.

Both
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01690117
IIA5-2512FSB552
No
No
Not Provided
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
October 2016

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