This trial is active, not recruiting.

Condition providing care for people with memory problems
Treatment building better caregivers small-group workshop
Sponsor Stanford University
Start date August 2014
End date July 2015
Trial size 250 participants
Trial identifier NCT02205671, 29894


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose prevention
Building Better Caregivers Small-group Workshop
building better caregivers small-group workshop

Primary Outcomes

time frame: baseline-1 year
time frame: baseline-1 year
time frame: baseline-1 year
problems sleeping
time frame: baseline-1 year
depression (PHQ-8)
time frame: baseline-1 year
self-efficacy for caregiving
time frame: baseline-1 year
caregiver stress
time frame: baseline-1 year
caregiver burden
time frame: baseline-1 year
health care utilization (doctor, emergency department, hospital)
time frame: baseline-1 year
time frame: baseline- 1 year
general health
time frame: baseline-1 year

Secondary Outcomes

care partner health utilization
time frame: baseline- 1 year
carepartners general health
time frame: baseline-1 year

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Family or friend caregiver of someone with cognitive impairment for at least 10 hours per week - 18 years of age or older - Able to attend a workshop 2.5 hours per week for 6 weeks - Speaks English Exclusion Criteria: - Professional caregiver - Under 18 years of age - Non-English speaking

Additional Information

Official title Building Better Caregivers: Development and Evaluation
Principal investigator Kate Lorig, DRPH
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Stanford University.