Building Better Caregivers: Development and Evaluation

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

Study Overview

• Status: Completed
• Conditions: Providing Care for People With Memory Problems
• Intervention / Treatment: Behavioral: Building Better Caregivers Small-group Workshop

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.

• Study Type: Interventional
• Enrollment (Actual): 128
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94304
      • Stanford University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Building Better Caregivers Small-group Workshop	Behavioral: Building Better Caregivers Small-group Workshop

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fatigue	visual numeric 0-10 scale	baseline-1 year
Pain	visual numeric 0-10 scale	baseline-1 year
stress	visual numeric 0-10 scale	baseline-1 year
problems sleeping	visual numeric 0-10 scale	baseline-1 year
depression (PHQ-8)	8 item 0-3 scale	baseline-1 year
self-efficacy for caregiving	9-item 1-10 scale	baseline-1 year
caregiver stress	13-item 3 point scale	baseline-1 year
caregiver burden	12-item 5 point scale	baseline-1 year
health care utilization (doctor, emergency department, hospital)	number of times/days in past 6 month visited doctor, emergency department, hospital	baseline-1 year
exercise	number of minutes of exercise in past week	baseline- 1 year
general health	single item scale of overall health	baseline-1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
care partner health utilization	number of MD ER hospital visits for person being cared for in past 6 months	baseline- 1 year
carepartners general health	single item scale of overall health of person being cared for	baseline-1 year

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Kate Lorig, DRPH, Stanford School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2014
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: July 29, 2014
• First Submitted That Met QC Criteria: July 30, 2014
• First Posted (Estimate): July 31, 2014

Study Record Updates

• Last Update Posted (Actual): April 25, 2017
• Last Update Submitted That Met QC Criteria: April 24, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: caregiving; chronic illness; patient education; self management
• Other Study ID Numbers: 29894

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No