Trial Outcomes & Findings for German Adaptation of REACH II (NCT NCT01690117)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

92 participants

Primary outcome timeframe

baseline and month 6

Results posted on

2016-11-29

Participant Flow

Participant milestones

Participant milestones
Measure	DeREACH-program DeREACH-program DeREACH-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	Control Group usual care The informal caregivers of the control group only receive the standard supply of health care Services.
Overall Study STARTED	47	45
Overall Study Post-Measurement	41	40
Overall Study COMPLETED	31	31
Overall Study NOT COMPLETED	16	14

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

German Adaptation of REACH II

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DeREACH-program n=47 Participants DeREACH-program DeREACH-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	Control Group n=45 Participants usual care The informal caregivers of the control group only receive the standard supply of health care Services.	Total n=92 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants	5 Participants n=7 Participants	14 Participants n=5 Participants
Age, Categorical >=65 years	38 Participants n=5 Participants	40 Participants n=7 Participants	78 Participants n=5 Participants
Age, Continuous	72.3 years STANDARD_DEVIATION 8.1 • n=5 Participants	73.9 years STANDARD_DEVIATION 8.2 • n=7 Participants	73.1 years STANDARD_DEVIATION 8.1 • n=5 Participants
Sex: Female, Male Female	32 Participants n=5 Participants	29 Participants n=7 Participants	61 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	16 Participants n=7 Participants	31 Participants n=5 Participants
Region of Enrollment Germany	47 participants n=5 Participants	45 participants n=7 Participants	92 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline and month 6

Population: The ZBI was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS (Statistical Package for the Social Sciences ) - methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.

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).

Outcome measures

Outcome measures
Measure	DeREACH-program n=41 Participants DeREACH-program DeREACH-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	Control Group n=40 Participants usual care The informal caregivers of the control group only receive the standard supply of health care Services.
Change From Baseline in Burden on the German Version of Zarit Caregiver Burden Interview (ZBI) (5-point Scale) at Month 6	-0.43 units on a scale Standard Deviation 8.41	7.05 units on a scale Standard Deviation 8.09

PRIMARY outcome

Timeframe: baseline and month 9

Population: The ZBI was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.

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).

Outcome measures

Outcome measures
Measure	DeREACH-program n=31 Participants DeREACH-program DeREACH-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	Control Group n=31 Participants usual care The informal caregivers of the control group only receive the standard supply of health care Services.
Change From Baseline in Burden on the German Version of Zarit Caregiver Burden Interview (ZBI) (5-point Scale) at Month 9	2.67 units on a scale Standard Deviation 8.86	8.10 units on a scale Standard Deviation 8.58

SECONDARY outcome

Timeframe: baseline and 6 month

Population: The PHQ - 15 was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.

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)

Outcome measures

Outcome measures
Measure	DeREACH-program n=41 Participants DeREACH-program DeREACH-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	Control Group n=40 Participants usual care The informal caregivers of the control group only receive the standard supply of health care Services.
Change From Baseline in Somatization on the Patient Health Questionaire - 15 Items (PHQ-15) - Module Somatization at Month 6	-1.40 units on a scale Standard Deviation 3.48	1.59 units on a scale Standard Deviation 5.32

SECONDARY outcome

Timeframe: baseline and month 9

Population: The PHQ - 15 was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.

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)

Outcome measures

Outcome measures
Measure	DeREACH-program n=31 Participants DeREACH-program DeREACH-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	Control Group n=31 Participants usual care The informal caregivers of the control group only receive the standard supply of health care Services.
Change From Baseline in Somatization on the Patient Health Questionaire - 15 Items (PHQ-15) - Module Somatization at Month 9	-0.60 units on a scale Standard Deviation 4.00	1.10 units on a scale Standard Deviation 2.77

SECONDARY outcome

Timeframe: baseline and month 6

Population: The PHQ-4 was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.

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)

Outcome measures

Outcome measures
Measure	DeREACH-program n=41 Participants DeREACH-program DeREACH-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	Control Group n=40 Participants usual care The informal caregivers of the control group only receive the standard supply of health care Services.
Change From Baseline in Mental Health on the Patient Health Questionnaire - 4 Items (PHQ-4) (4-point Scale) at Month 6	-0.66 units on a scale Standard Deviation 3.09	0.05 units on a scale Standard Deviation 3.05

SECONDARY outcome

Timeframe: baseline and month 9

Population: The PHQ-4 was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.

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)

Outcome measures

Outcome measures
Measure	DeREACH-program n=31 Participants DeREACH-program DeREACH-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	Control Group n=31 Participants usual care The informal caregivers of the control group only receive the standard supply of health care Services.
Change From Baseline in Mental Health on the Patient Health Questionnaire - 4 Items (PHQ-4) (4-point Scale) at Month 9	-0.29 units on a scale Standard Deviation 2.65	0.68 units on a scale Standard Deviation 3.67

SECONDARY outcome

Timeframe: baseline and month 6

Population: The ESSI was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.

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)

Outcome measures

Outcome measures
Measure	DeREACH-program n=41 Participants DeREACH-program DeREACH-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	Control Group n=40 Participants usual care The informal caregivers of the control group only receive the standard supply of health care Services.
Change From Baseline in Social Support on the ENRICHED-Social-Support-Instrument (ESSI) (5-point Scale) at Month 6	0.66 units on a scale Standard Deviation 4.86	0.21 units on a scale Standard Deviation 4.45

SECONDARY outcome

Timeframe: baseline and month 9

Population: The ESSI was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.

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)

Outcome measures

Outcome measures
Measure	DeREACH-program n=31 Participants DeREACH-program DeREACH-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	Control Group n=31 Participants usual care The informal caregivers of the control group only receive the standard supply of health care Services.
Change From Baseline in Social Support on the ENRICHED-Social-Support-Instrument (ESSI) (5-point Scale) at Month 9	-0.55 units on a scale Standard Deviation 5.39	-0.74 units on a scale Standard Deviation 4.12

SECONDARY outcome

Timeframe: baseline and month 6

Population: The SF-12 -mental component was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.

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)

Outcome measures

Outcome measures
Measure	DeREACH-program n=41 Participants DeREACH-program DeREACH-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	Control Group n=40 Participants usual care The informal caregivers of the control group only receive the standard supply of health care Services.
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 units on a scale Standard Deviation 8.70	-2.53 units on a scale Standard Deviation 8.56

SECONDARY outcome

Timeframe: baseline and month 9

Population: The SF-12 -mental component was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.

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)

Outcome measures

Outcome measures
Measure	DeREACH-program n=31 Participants DeREACH-program DeREACH-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	Control Group n=31 Participants usual care The informal caregivers of the control group only receive the standard supply of health care Services.
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 units on a scale Standard Deviation 10.66	-4.62 units on a scale Standard Deviation 8.16

SECONDARY outcome

Timeframe: baseline and month 6

Population: The SF-12 -mental component was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.

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)

Outcome measures

Outcome measures
Measure	DeREACH-program n=41 Participants DeREACH-program DeREACH-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	Control Group n=40 Participants usual care The informal caregivers of the control group only receive the standard supply of health care Services.
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 units on a scale Standard Deviation 9.96	-1.31 units on a scale Standard Deviation 7.71

SECONDARY outcome

Timeframe: baseline and month 9

Population: The SF-12 - physical component was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.

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)

Outcome measures

Outcome measures
Measure	DeREACH-program n=31 Participants DeREACH-program DeREACH-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	Control Group n=31 Participants usual care The informal caregivers of the control group only receive the standard supply of health care Services.
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 units on a scale Standard Deviation 9.59	0.19 units on a scale Standard Deviation 6.70

SECONDARY outcome

Timeframe: baseline and month 6

Population: The RMBPC - frequency subscale was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.

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)

Outcome measures

Outcome measures
Measure	DeREACH-program n=41 Participants DeREACH-program DeREACH-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	Control Group n=40 Participants usual care The informal caregivers of the control group only receive the standard supply of health care Services.
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 units on a scale Standard Deviation 7.21	1.29 units on a scale Standard Deviation 5.89

SECONDARY outcome

Timeframe: baseline and month 9

Population: The RMBPC - frequency subscale was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.

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)

Outcome measures

Outcome measures
Measure	DeREACH-program n=31 Participants DeREACH-program DeREACH-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	Control Group n=31 Participants usual care The informal caregivers of the control group only receive the standard supply of health care Services.
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 units on a scale Standard Deviation 8.02	3.09 units on a scale Standard Deviation 7.00

SECONDARY outcome

Timeframe: baseline and month 6

Population: The RMBPC reaction subscale was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.

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)

Outcome measures

Outcome measures
Measure	DeREACH-program n=41 Participants DeREACH-program DeREACH-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	Control Group n=40 Participants usual care The informal caregivers of the control group only receive the standard supply of health care Services.
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 units on a scale Standard Deviation 7.26	2.34 units on a scale Standard Deviation 6.38

SECONDARY outcome

Timeframe: baseline and month 9

Population: The RMBPC reaction subscale was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.

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)

Outcome measures

Outcome measures
Measure	DeREACH-program n=31 Participants DeREACH-program DeREACH-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	Control Group n=31 Participants usual care The informal caregivers of the control group only receive the standard supply of health care Services.
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 units on a scale Standard Deviation 7.87	3.24 units on a scale Standard Deviation 7.00

Adverse Events

Intervention Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Prof. Dr. Hermann-Josef Gertz

University of Leipzig, Medical Faculty, Clinic and Policlinic for Psychiatry and Psychotherapy

Phone: 0049 (0)341 97 24420

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place