- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01690117
German Adaptation of REACH II (GE-REACH)
German Adaptation of Resources to Enhance Alzheimer's Caregiver Health
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Saxonia
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Leipzig, Saxonia, Germania, 04103
- Klinik und Poliklinik für Psychiatrie und Psychotherapie
-
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: 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
|
Nessun intervento: gruppo di controllo
consueta cura
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Change From Baseline in Burden on the German Version of Zarit Caregiver Burden Interview (ZBI) (5-point Scale) at Month 6
Lasso di tempo: 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
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Change From Baseline in Somatization on the Patient Health Questionaire - 15 Items (PHQ-15) - Module Somatization at Month 6
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Hermann-Josef Gertz, Prof. Dr., Klinik und Poliklinik für Psychiatrie der Universität Leipzig
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
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Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
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Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- IIA5-2512FSB552
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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