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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GE-REACH-program | Experimental | GE-REACH-program |
|
| control group | No Intervention | usual care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GE-REACH-program | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | baseline and 6 month |
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Inclusion criteria
Exclusion criteria
Other requirements were logistic, including having a telephone, planning to remain in the geographic area for at least 6 months, and competency in German.
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| Name | Affiliation | Role |
|---|---|---|
| Hermann-Josef Gertz, Prof. Dr. | Klinik und Poliklinik für Psychiatrie der Universität Leipzig | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinik und Poliklinik für Psychiatrie und Psychotherapie | Leipzig | Saxony | 04103 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17116917 | Background | 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. | |
| 29233097 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Control Group | usual care The informal caregivers of the control group only receive the standard supply of health care Services. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Control Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | 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. | Posted | Mean | Standard Deviation | units on a scale | baseline and month 6 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Group | Serious and Other [Not Including Serious] Adverse Events were not monitored/assessed. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Dr. Hermann-Josef Gertz | University of Leipzig, Medical Faculty, Clinic and Policlinic for Psychiatry and Psychotherapy | 0049 (0)341 97 24420 | Hermann-Josef.Gertz@medizin.uni-leipzig.de |
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| ID | Term |
|---|---|
| D003704 | Dementia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
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| 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) | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 |
| Derived |
| 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. |
| 24520910 | Derived | 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. |
usual care The informal caregivers of the control group only receive the standard supply of health care Services. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Control Group | usual care The informal caregivers of the control group only receive the standard supply of health care Services. |
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| 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). | 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. | Posted | Mean | Standard Deviation | units on a scale | baseline and month 9 |
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| 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) | 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. | Posted | Mean | Standard Deviation | units on a scale | baseline and 6 month |
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| 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) | 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. | Posted | Mean | Standard Deviation | units on a scale | baseline and month 9 |
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| 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) | 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. | Posted | Mean | Standard Deviation | units on a scale | baseline and month 6 |
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| 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) | 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. | Posted | Mean | Standard Deviation | units on a scale | baseline and month 9 |
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| 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) | 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. | Posted | Mean | Standard Deviation | units on a scale | baseline and month 6 |
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| 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) | 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. | Posted | Mean | Standard Deviation | units on a scale | baseline and month 9 |
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| 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) | 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. | Posted | Mean | Standard Deviation | units on a scale | baseline and month 6 |
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| 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) | 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. | Posted | Mean | Standard Deviation | units on a scale | baseline and month 9 |
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| 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) | 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. | Posted | Mean | Standard Deviation | units on a scale | baseline and month 6 |
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| 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) | 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. | Posted | Mean | Standard Deviation | units on a scale | baseline and month 9 |
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| 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) | 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. | Posted | Mean | Standard Deviation | units on a scale | baseline and month 6 |
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| 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) | 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. | Posted | Mean | Standard Deviation | units on a scale | baseline and month 9 |
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| 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) | 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. | Posted | Mean | Standard Deviation | units on a scale | baseline and month 6 |
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| 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) | 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. | Posted | Mean | Standard Deviation | units on a scale | baseline and month 9 |
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| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Control Group | Serious and Other [Not Including Serious] Adverse Events were not monitored/assessed. | 0 | 0 | 0 | 0 |
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| D001523 | Mental Disorders |