Dementia, Family Caregiver
Conditions
Keywords
family caregiver, dementia, intervention, implementation
Brief 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.
Detailed description
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.
Interventions
BEHAVIORALGE-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
Sponsors
University of Leipzig
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Burden on the German Version of Zarit Caregiver Burden Interview (ZBI) (5-point Scale) at Month 6 | 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). |
| Change From Baseline in Burden on the German Version of Zarit Caregiver Burden Interview (ZBI) (5-point Scale) at Month 9 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Mental Health on the Patient Health Questionnaire - 4 Items (PHQ-4) (4-point Scale) at Month 6 | 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) |
| Change From Baseline in Mental Health on the Patient Health Questionnaire - 4 Items (PHQ-4) (4-point Scale) at Month 9 | 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) |
| Change From Baseline in Social Support on the ENRICHED-Social-Support-Instrument (ESSI) (5-point Scale) at Month 6 | 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) |
| Change From Baseline in Social Support on the ENRICHED-Social-Support-Instrument (ESSI) (5-point Scale) at Month 9 | 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) |
| 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 | 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) |
| 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 | 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) |
| Change From Baseline in Somatization on the Patient Health Questionaire - 15 Items (PHQ-15) - Module Somatization at Month 6 | 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) |
| 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 | 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) |
| 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 | 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) |
| 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 | 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) |
| 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 | 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) |
| 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 | 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) |
| 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 | 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) |
| Change From Baseline in Somatization on the Patient Health Questionaire - 15 Items (PHQ-15) - Module Somatization at Month 9 | 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) |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 47 |
| Control Group usual care
The informal caregivers of the control group only receive the standard supply of health care Services. | 45 |
| Total | 92 |
Baseline characteristics
| Characteristic | Control Group | DeREACH-program | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 40 Participants | 38 Participants | 78 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 9 Participants | 14 Participants |
| Age, Continuous | 73.9 years STANDARD_DEVIATION 8.2 | 72.3 years STANDARD_DEVIATION 8.1 | 73.1 years STANDARD_DEVIATION 8.1 |
| Region of Enrollment Germany | 45 participants | 47 participants | 92 participants |
| Sex: Female, Male Female | 29 Participants | 32 Participants | 61 Participants |
| Sex: Female, Male Male | 16 Participants | 15 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Change From Baseline in Burden on the German Version of Zarit Caregiver Burden Interview (ZBI) (5-point Scale) at 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).
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DeREACH-program | 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 |
| Control Group | Change From Baseline in Burden on the German Version of Zarit Caregiver Burden Interview (ZBI) (5-point Scale) at Month 6 | 7.05 units on a scale | Standard Deviation 8.09 |
p-value: <0.00195% CI: [3.82, 11.12]t-test, 2 sided
Primary
Change From Baseline in Burden on the German Version of Zarit Caregiver Burden Interview (ZBI) (5-point Scale) at 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).
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DeREACH-program | 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 |
| Control Group | Change From Baseline in Burden on the German Version of Zarit Caregiver Burden Interview (ZBI) (5-point Scale) at Month 9 | 8.10 units on a scale | Standard Deviation 8.58 |
p-value: <0.0595% CI: [1, 9.86]t-test, 2 sided
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
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)
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DeREACH-program | 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 |
| Control Group | 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 | 1.29 units on a scale | Standard Deviation 5.89 |
p-value: 0.0595% CI: [-0.01, 5.81]t-test, 2 sided
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
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)
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DeREACH-program | 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 |
| Control Group | 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 | 3.09 units on a scale | Standard Deviation 7 |
p-value: <0.0595% CI: [0.68, 8.33]t-test, 2 sided
Secondary
Change From Baseline in Mental Health on the Patient Health Questionnaire - 4 Items (PHQ-4) (4-point Scale) at 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)
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DeREACH-program | 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 |
| Control Group | Change From Baseline in Mental Health on the Patient Health Questionnaire - 4 Items (PHQ-4) (4-point Scale) at Month 6 | 0.05 units on a scale | Standard Deviation 3.05 |
p-value: 0.395% CI: [-0.65, 2.07]t-test, 2 sided
Secondary
Change From Baseline in Mental Health on the Patient Health Questionnaire - 4 Items (PHQ-4) (4-point Scale) at 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)
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DeREACH-program | 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 |
| Control Group | Change From Baseline in Mental Health on the Patient Health Questionnaire - 4 Items (PHQ-4) (4-point Scale) at Month 9 | 0.68 units on a scale | Standard Deviation 3.67 |
p-value: 0.2495% CI: [-0.66, 2.59]t-test, 2 sided
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
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)
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DeREACH-program | 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 |
| Control Group | 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 | -1.31 units on a scale | Standard Deviation 7.71 |
p-value: 0.0595% CI: [-7.86, 0.04]t-test, 2 sided
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
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)
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DeREACH-program | 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 |
| Control Group | 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 | 0.19 units on a scale | Standard Deviation 6.7 |
p-value: 0.9195% CI: [-3.96, 4.45]t-test, 2 sided
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
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)
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DeREACH-program | 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 8.7 |
| Control Group | 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 | -2.53 units on a scale | Standard Deviation 8.56 |
p-value: <0.0595% CI: [-8.74, -1.11]t-test, 2 sided
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
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)
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DeREACH-program | 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 |
| Control Group | 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 | -4.62 units on a scale | Standard Deviation 8.16 |
p-value: <0.00195% CI: [-13.31, -3.66]t-test, 2 sided
Secondary
Change From Baseline in Social Support on the ENRICHED-Social-Support-Instrument (ESSI) (5-point Scale) at 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)
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DeREACH-program | 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 |
| Control Group | Change From Baseline in Social Support on the ENRICHED-Social-Support-Instrument (ESSI) (5-point Scale) at Month 6 | 0.21 units on a scale | Standard Deviation 4.45 |
p-value: <0.0595% CI: [-2.5, 1.62]t-test, 2 sided
Secondary
Change From Baseline in Social Support on the ENRICHED-Social-Support-Instrument (ESSI) (5-point Scale) at 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)
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DeREACH-program | 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 |
| Control Group | Change From Baseline in Social Support on the ENRICHED-Social-Support-Instrument (ESSI) (5-point Scale) at Month 9 | -0.74 units on a scale | Standard Deviation 4.12 |
p-value: 0.8895% CI: [-2.63, 2.25]t-test, 2 sided
Secondary
Change From Baseline in Somatization on the Patient Health Questionaire - 15 Items (PHQ-15) - Module Somatization at Month 6
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)
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DeREACH-program | 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 |
| Control Group | Change From Baseline in Somatization on the Patient Health Questionaire - 15 Items (PHQ-15) - Module Somatization at Month 6 | 1.59 units on a scale | Standard Deviation 5.32 |
p-value: <0.0195% CI: [1.01, 4.97]t-test, 2 sided
Secondary
Change From Baseline in Somatization on the Patient Health Questionaire - 15 Items (PHQ-15) - Module Somatization at 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)
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DeREACH-program | 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 |
| Control Group | Change From Baseline in Somatization on the Patient Health Questionaire - 15 Items (PHQ-15) - Module Somatization at Month 9 | 1.10 units on a scale | Standard Deviation 2.77 |
p-value: 0.0695% CI: [-0.05, 3.45]t-test, 2 sided
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
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)
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DeREACH-program | 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 |
| Control Group | 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 | 2.34 units on a scale | Standard Deviation 6.38 |
p-value: <0.0195% CI: [-8.4, -0.65]t-test, 2 sided
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
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)
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DeREACH-program | 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 |
| Control Group | 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 | 3.24 units on a scale | Standard Deviation 7 |
p-value: <0.0195% CI: [4.78, 10.83]t-test, 2 sided