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German Adaptation of REACH II (GE-REACH)

5 oktober 2016 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

92

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Duitsland
    • Saxonia
      • Leipzig, Saxonia, Duitsland, 04103
        • Klinik und Poliklinik für Psychiatrie und Psychotherapie

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind
  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: GE-REACH-program
Gedragsmatig: 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
Geen tussenkomst: controlegroep
Gebruikelijke zorg

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change From Baseline in Burden on the German Version of Zarit Caregiver Burden Interview (ZBI) (5-point Scale) at Month 6
Tijdsspanne: 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
Change From Baseline in Burden on the German Version of Zarit Caregiver Burden Interview (ZBI) (5-point Scale) at Month 9
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change From Baseline in Somatization on the Patient Health Questionaire - 15 Items (PHQ-15) - Module Somatization at Month 6
Tijdsspanne: 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
Change From Baseline in Somatization on the Patient Health Questionaire - 15 Items (PHQ-15) - Module Somatization at Month 9
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Leipzig

Onderzoekers

  • Hoofdonderzoeker: Hermann-Josef Gertz, Prof. Dr., Klinik und Poliklinik für Psychiatrie der Universität Leipzig

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 oktober 2012

Primaire voltooiing (Werkelijk)

1 januari 2015

Studie voltooiing (Werkelijk)

1 januari 2015

Studieregistratiedata

Eerst ingediend

17 september 2012

Eerst ingediend dat voldeed aan de QC-criteria

20 september 2012

Eerst geplaatst (Schatting)

21 september 2012

Updates van studierecords

Laatste update geplaatst (Schatting)

29 november 2016

Laatste update ingediend die voldeed aan QC-criteria

5 oktober 2016

Laatst geverifieerd

1 oktober 2016

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • IIA5-2512FSB552

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

Nee

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