Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

German Adaptation of REACH II (GE-REACH)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hermann-Josef Gertz, University of Leipzig
ClinicalTrials.gov Identifier:
NCT01690117
First received: September 17, 2012
Last updated: October 5, 2016
Last verified: October 2016
Results First Received: July 1, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Dementia
Family Caregiver
Intervention: Behavioral: GE-REACH-program

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.


Participant Flow:   Overall Study
    DeREACH-program   Control Group
STARTED   47   45 
Post-Measurement   41   40 
COMPLETED   31   31 
NOT COMPLETED   16   14 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

Total Total of all reporting groups

Baseline Measures
   DeREACH-program   Control Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 47   45   92 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   9   5   14 
>=65 years   38   40   78 
Age 
[Units: Years]
Mean (Standard Deviation)
 72.3  (8.1)   73.9  (8.2)   73.1  (8.1) 
Gender 
[Units: Participants]
     
Female   32   29   61 
Male   15   16   31 
Region of Enrollment 
[Units: Participants]
     
Germany   47   45   92 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Burden on the German Version of Zarit Caregiver Burden Interview (ZBI) (5-point Scale) at Month 6   [ Time Frame: baseline and month 6 ]

2.  Primary:   Change From Baseline in Burden on the German Version of Zarit Caregiver Burden Interview (ZBI) (5-point Scale) at Month 9   [ Time Frame: baseline and month 9 ]

3.  Secondary:   Change From Baseline in Somatization on the Patient Health Questionaire - 15 Items (PHQ-15) - Module Somatization at Month 6   [ Time Frame: baseline and 6 month ]

4.  Secondary:   Change From Baseline in Somatization on the Patient Health Questionaire - 15 Items (PHQ-15) - Module Somatization at Month 9   [ Time Frame: baseline and month 9 ]

5.  Secondary:   Change From Baseline in Mental Health on the Patient Health Questionnaire - 4 Items (PHQ-4) (4-point Scale) at Month 6   [ Time Frame: baseline and month 6 ]

6.  Secondary:   Change From Baseline in Mental Health on the Patient Health Questionnaire - 4 Items (PHQ-4) (4-point Scale) at Month 9   [ Time Frame: baseline and month 9 ]

7.  Secondary:   Change From Baseline in Social Support on the ENRICHED-Social-Support-Instrument (ESSI) (5-point Scale) at Month 6   [ Time Frame: baseline and month 6 ]

8.  Secondary:   Change From Baseline in Social Support on the ENRICHED-Social-Support-Instrument (ESSI) (5-point Scale) at Month 9   [ Time Frame: baseline and month 9 ]

9.  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   [ Time Frame: baseline and month 6 ]

10.  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   [ Time Frame: baseline and month 9 ]

11.  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   [ Time Frame: baseline and month 6 ]

12.  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   [ Time Frame: baseline and month 9 ]

13.  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   [ Time Frame: baseline and month 6 ]

14.  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   [ Time Frame: baseline and month 9 ]

15.  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   [ Time Frame: baseline and month 6 ]

16.  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   [ Time Frame: baseline and month 9 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Prof. Dr. Hermann-Josef Gertz
Organization: University of Leipzig, Medical Faculty, Clinic and Policlinic for Psychiatry and Psychotherapy
phone: 0049 (0)341 97 24420
e-mail: Hermann-Josef.Gertz@medizin.uni-leipzig.de


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Hermann-Josef Gertz, University of Leipzig
ClinicalTrials.gov Identifier: NCT01690117     History of Changes
Other Study ID Numbers: IIA5-2512FSB552
Study First Received: September 17, 2012
Results First Received: July 1, 2016
Last Updated: October 5, 2016
Health Authority: Germany: Ministry of Health