German Adaptation of REACH II (GE-REACH)
5 oktober 2016 uppdaterad av: Hermann-Josef Gertz, University of Leipzig
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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
92
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Saxonia
-
Leipzig, Saxonia, Tyskland, 04103
- Klinik und Poliklinik für Psychiatrie und Psychotherapie
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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
|
|
Inget ingripande: kontrollgrupp
vanlig skötsel
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change From Baseline in Burden on the German Version of Zarit Caregiver Burden Interview (ZBI) (5-point Scale) at Month 6
Tidsram: baseline and month 6
|
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).
|
baseline and month 6
|
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Change From Baseline in Burden on the German Version of Zarit Caregiver Burden Interview (ZBI) (5-point Scale) at Month 9
Tidsram: baseline and month 9
|
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).
|
baseline and month 9
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change From Baseline in Somatization on the Patient Health Questionaire - 15 Items (PHQ-15) - Module Somatization at Month 6
Tidsram: baseline and 6 month
|
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)
|
baseline and 6 month
|
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Change From Baseline in Somatization on the Patient Health Questionaire - 15 Items (PHQ-15) - Module Somatization at Month 9
Tidsram: baseline and month 9
|
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)
|
baseline and month 9
|
|
Change From Baseline in Mental Health on the Patient Health Questionnaire - 4 Items (PHQ-4) (4-point Scale) at Month 6
Tidsram: baseline and month 6
|
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)
|
baseline and month 6
|
|
Change From Baseline in Mental Health on the Patient Health Questionnaire - 4 Items (PHQ-4) (4-point Scale) at Month 9
Tidsram: baseline and month 9
|
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)
|
baseline and month 9
|
|
Change From Baseline in Social Support on the ENRICHED-Social-Support-Instrument (ESSI) (5-point Scale) at Month 6
Tidsram: baseline and month 6
|
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)
|
baseline and month 6
|
|
Change From Baseline in Social Support on the ENRICHED-Social-Support-Instrument (ESSI) (5-point Scale) at Month 9
Tidsram: baseline and month 9
|
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)
|
baseline and month 9
|
|
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
Tidsram: baseline and month 6
|
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)
|
baseline and month 6
|
|
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
Tidsram: baseline and month 9
|
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)
|
baseline and month 9
|
|
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
Tidsram: baseline and month 6
|
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)
|
baseline and month 6
|
|
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
Tidsram: baseline and month 9
|
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)
|
baseline and month 9
|
|
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
Tidsram: baseline and month 6
|
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)
|
baseline and month 6
|
|
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
Tidsram: baseline and month 9
|
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)
|
baseline and month 9
|
|
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
Tidsram: baseline and month 6
|
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)
|
baseline and month 6
|
|
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
Tidsram: baseline and month 9
|
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)
|
baseline and month 9
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Hermann-Josef Gertz, Prof. Dr., Klinik und Poliklinik für Psychiatrie der Universität Leipzig
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
- 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.
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 oktober 2012
Primärt slutförande (Faktisk)
1 januari 2015
Avslutad studie (Faktisk)
1 januari 2015
Studieregistreringsdatum
Först inskickad
17 september 2012
Först inskickad som uppfyllde QC-kriterierna
20 september 2012
Första postat (Uppskatta)
21 september 2012
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
29 november 2016
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
5 oktober 2016
Senast verifierad
1 oktober 2016
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- IIA5-2512FSB552
Plan för individuella deltagardata (IPD)
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Nej
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