Clinical trial NCT02205671: Building Better Caregivers: Development and Evaluation
Official title: Building Better Caregivers: Development and Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Providing Care for People With Memory Problems
Keywords: caregiving
chronic illness
patient education
self management
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2014-07-31
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Fatigue
timeFrame: baseline-1 year
measure: Pain
timeFrame: baseline-1 year
measure: stress
timeFrame: baseline-1 year
measure: problems sleeping
timeFrame: baseline-1 year
measure: depression (PHQ-8)
timeFrame: baseline-1 year
measure: self-efficacy for caregiving
timeFrame: baseline-1 year
measure: caregiver stress
timeFrame: baseline-1 year
measure: caregiver burden
timeFrame: baseline-1 year
measure: health care utilization (doctor, emergency department, hospital)
timeFrame: baseline-1 year
measure: exercise
timeFrame: baseline- 1 year
measure: general health
timeFrame: baseline-1 year
Secondary outcomes:
measure: care partner health utilization
timeFrame: baseline- 1 year
measure: carepartners general health
timeFrame: baseline-1 year
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford School of Medicine
name: Kate Lorig, DRPH
role: PRINCIPAL_INVESTIGATOR
References: