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Clinical Trials/NCT02205671
NCT02205671
Completed
Not Applicable

Building Better Caregivers: Development and Evaluation

Stanford University1 site in 1 country128 target enrollmentAugust 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Providing Care for People With Memory Problems
Sponsor
Stanford University
Enrollment
128
Locations
1
Primary Endpoint
caregiver burden
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

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

Detailed 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.

Registry
clinicaltrials.gov
Start Date
August 2014
End Date
March 2017
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kate Lorig

Professor Emeritus

Stanford University

Eligibility Criteria

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

Outcomes

Primary Outcomes

caregiver burden

Time Frame: baseline-1 year

12-item 5 point scale

depression (PHQ-8)

Time Frame: baseline-1 year

8 item 0-3 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

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

general health

Time Frame: baseline-1 year

single item scale of overall health

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

exercise

Time Frame: baseline- 1 year

number of minutes of exercise in past week

Secondary Outcomes

  • care partner health utilization(baseline- 1 year)
  • carepartners general health(baseline-1 year)

Study Sites (1)

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