German Adaptation of REACH II (GE-REACH)
5 octobre 2016 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
92
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Saxonia
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Leipzig, Saxonia, Allemagne, 04103
- Klinik und Poliklinik für Psychiatrie und Psychotherapie
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: GE-REACH-program
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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
|
|
Aucune intervention: groupe de contrôle
soins habituels
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change From Baseline in Burden on the German Version of Zarit Caregiver Burden Interview (ZBI) (5-point Scale) at Month 6
Délai: 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
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change From Baseline in Somatization on the Patient Health Questionaire - 15 Items (PHQ-15) - Module Somatization at Month 6
Délai: baseline and 6 month
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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
Délai: 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
|
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Change From Baseline in Mental Health on the Patient Health Questionnaire - 4 Items (PHQ-4) (4-point Scale) at Month 6
Délai: 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
|
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Change From Baseline in Mental Health on the Patient Health Questionnaire - 4 Items (PHQ-4) (4-point Scale) at Month 9
Délai: 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
|
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Change From Baseline in Social Support on the ENRICHED-Social-Support-Instrument (ESSI) (5-point Scale) at Month 6
Délai: 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
|
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Change From Baseline in Social Support on the ENRICHED-Social-Support-Instrument (ESSI) (5-point Scale) at Month 9
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
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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
Délai: 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
|
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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
Délai: 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
|
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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
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Hermann-Josef Gertz, Prof. Dr., Klinik und Poliklinik für Psychiatrie der Universität Leipzig
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 octobre 2012
Achèvement primaire (Réel)
1 janvier 2015
Achèvement de l'étude (Réel)
1 janvier 2015
Dates d'inscription aux études
Première soumission
17 septembre 2012
Première soumission répondant aux critères de contrôle qualité
20 septembre 2012
Première publication (Estimation)
21 septembre 2012
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
29 novembre 2016
Dernière mise à jour soumise répondant aux critères de contrôle qualité
5 octobre 2016
Dernière vérification
1 octobre 2016
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- IIA5-2512FSB552
Plan pour les données individuelles des participants (IPD)
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Non
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