Building Better Caregivers: Development and Evaluation
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|ClinicalTrials.gov Identifier: NCT02205671|
Recruitment Status : Completed
First Posted : July 31, 2014
Last Update Posted : April 25, 2017
The program consists of a 6-week small-group workshop for caregivers of people with memory problems.
The goal of the study is to evaluate in a one year longitudinal study, program effectiveness in reducing caregiver stress, depression, fatigue, burden, days lost from work and improving sleep, healthful behaviors and self-efficacy
|Condition or disease||Intervention/treatment||Phase|
|Providing Care for People With Memory Problems||Behavioral: Building Better Caregivers Small-group Workshop||Not Applicable|
The Building Better Caregivers workshop meets for 2.5 hours per week for 6 weeks in small groups of 10-16. It is peer-led (leaders already trained in the Stanford model must take a 2-day cross-training before leading a BBC workshop).
Participants will learn self-management skills such as decision making, goal setting, action planning, stress management, dealing with difficult behaviors, working with the health care system, planning for the future,building an exercise program, communication skills, healthy eating, etc.
All participants will complete follow up questionnaires and 6 and 12 months. They will have the option of completing the questionnaire by mail or telephone interview.
Once a particular workshop site is identified by a partner organization, Stanford will provide packets of consents and questionnaires to the site coordinator(non-Stanford). The site coordinator will either schedule an extra hour for the first meeting of the 6-week series, or an orientation meeting held a week or so before the workshop begins. During this time, the coordinator will announce to the prospective subjects that this study is being conducted and that they are invited to participate, and will pass out a consent, questionnaire and consent copy to each prospective participant. The consent and questionnaire are self-administered.
This study is longitudinal, so no randomization will take place.
Stanford holds no meetings, but receives the data. The site coordinators hold the orientation meetings. The workshops are scheduled by the various organizations, and they determine when and how the orientation time is scheduled. It will vary from site to site.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||128 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Building Better Caregivers: Development and Evaluation|
|Actual Study Start Date :||August 2014|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||March 2017|
Building Better Caregivers Small-group Workshop
Behavioral: Building Better Caregivers Small-group Workshop
- Fatigue [ Time Frame: baseline-1 year ]visual numeric 0-10 scale
- Pain [ Time Frame: baseline-1 year ]visual numeric 0-10 scale
- stress [ Time Frame: baseline-1 year ]visual numeric 0-10 scale
- problems sleeping [ Time Frame: baseline-1 year ]visual numeric 0-10 scale
- depression (PHQ-8) [ Time Frame: baseline-1 year ]8 item 0-3 scale
- self-efficacy for caregiving [ Time Frame: baseline-1 year ]9-item 1-10 scale
- caregiver stress [ Time Frame: baseline-1 year ]13-item 3 point scale
- caregiver burden [ Time Frame: baseline-1 year ]12-item 5 point scale
- health care utilization (doctor, emergency department, hospital) [ Time Frame: baseline-1 year ]number of times/days in past 6 month visited doctor, emergency department, hospital
- exercise [ Time Frame: baseline- 1 year ]number of minutes of exercise in past week
- general health [ Time Frame: baseline-1 year ]single item scale of overall health
- care partner health utilization [ Time Frame: baseline- 1 year ]number of MD ER hospital visits for person being cared for in past 6 months
- carepartners general health [ Time Frame: baseline-1 year ]single item scale of overall health of person being cared for
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02205671
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94304|
|Principal Investigator:||Kate Lorig, DRPH||Stanford School of Medicine|