NCT01690117

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 17, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 21, 2012

Completed
10 days until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

November 29, 2016

Completed
Last Updated

November 29, 2016

Status Verified

October 1, 2016

Enrollment Period

2.3 years

First QC Date

September 17, 2012

Results QC Date

July 1, 2016

Last Update Submit

October 5, 2016

Conditions

DementiaFamily Caregiver

Keywords

family caregiverdementiainterventionimplementation

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (14)

  • Change From Baseline in Somatization on the Patient Health Questionaire - 15 Items (PHQ-15) - Module Somatization at Month 6

    baseline and 6 month

  • Change From Baseline in Somatization on the Patient Health Questionaire - 15 Items (PHQ-15) - Module Somatization at Month 9

    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

    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

    baseline and month 9

  • Change From Baseline in Social Support on the ENRICHED-Social-Support-Instrument (ESSI) (5-point Scale) at Month 6

    baseline and month 6

  • +9 more secondary outcomes

Study Arms (2)

GE-REACH-program

EXPERIMENTAL

GE-REACH-program

Behavioral: GE-REACH-program

control group

NO INTERVENTION

usual care

Interventions

GE-REACH-programBEHAVIORAL

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

GE-REACH-program

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinik und Poliklinik für Psychiatrie und Psychotherapie

Leipzig, Saxony, 04103, Germany

Location

Related Publications (3)

  • 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.

    PMID: 17116917BACKGROUND

  • 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.

    PMID: 29233097DERIVED

  • 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.

    PMID: 24520910DERIVED

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Results Point of Contact

Title
Prof. Dr. Hermann-Josef Gertz
Organization
University of Leipzig, Medical Faculty, Clinic and Policlinic for Psychiatry and Psychotherapy
Hermann-Josef.Gertz@medizin.uni-leipzig.de
0049 (0)341 97 24420

Study Officials

  • Hermann-Josef Gertz, Prof. Dr.

    Klinik und Poliklinik für Psychiatrie der Universität Leipzig

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

September 17, 2012

First Posted

September 21, 2012

Study Start

October 1, 2012

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

November 29, 2016

Results First Posted

November 29, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)