N/A N=92 Randomized Treatment

German Adaptation of REACH II

Dementia · Family Caregiver

Bottom Line

View on ClinicalTrials.gov: NCT01690117 ↗

Enrolled (actual)

Serious AEs

—

Results posted

Nov 2016

Primary outcome: Primary: Change From Baseline in Burden on the German Version of Zarit Caregiver Burden Interview (ZBI) (5-point Scale) at Month 6 — -0.43; 7.05 units on a scale — p=<0.001

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: GE-REACH-program (Behavioral)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: University of Leipzig
Primary completion: Jan 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Burden on the German Version of Zarit Caregiver Burden Interview (ZBI) (5-point Scale) at Month 6	-0.43; 7.05	<0.001 sig
PRIMARY Change From Baseline in Burden on the German Version of Zarit Caregiver Burden Interview (ZBI) (5-point Scale) at Month 9	2.67; 8.10	<0.05 sig
SECONDARY Change From Baseline in Somatization on the Patient Health Questionaire - 15 Items (PHQ-15) - Module Somatization at Month 6	-1.40; 1.59	<0.01 sig
SECONDARY Change From Baseline in Somatization on the Patient Health Questionaire - 15 Items (PHQ-15) - Module Somatization at Month 9	-0.60; 1.10	0.06
SECONDARY Change From Baseline in Mental Health on the Patient Health Questionnaire - 4 Items (PHQ-4) (4-point Scale) at Month 6	-0.66; 0.05	0.30
SECONDARY Change From Baseline in Mental Health on the Patient Health Questionnaire - 4 Items (PHQ-4) (4-point Scale) at Month 9	-0.29; 0.68	0.24
SECONDARY Change From Baseline in Social Support on the ENRICHED-Social-Support-Instrument (ESSI) (5-point Scale) at Month 6	0.66; 0.21	<0.05 sig
SECONDARY Change From Baseline in Social Support on the ENRICHED-Social-Support-Instrument (ESSI) (5-point Scale) at Month 9	-0.55; -0.74	0.88
SECONDARY 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	2.40; -2.53	<0.05 sig
SECONDARY 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	3.87; -4.62	<0.001 sig
SECONDARY 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	2.60; -1.31	0.05
SECONDARY 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	-0.05; 0.19	0.91
SECONDARY 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	-1.62; 1.29	0.05
SECONDARY 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	1.41; 3.09	<0.05 sig
SECONDARY 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	-5.46; 2.34	<0.01 sig
SECONDARY 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	-6.17; 3.24	<0.01 sig

Summary

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01690117). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.