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Completed

NCT Number: NCT02205671

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University School of Medicine

Stanford, California, 94304, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Building Better Caregivers Small-group Workshop

Behavioral

Primary outcomes

  1. Fatigue

    Time frame: baseline-1 year

    visual numeric 0-10 scale

  2. Pain

    Time frame: baseline-1 year

    visual numeric 0-10 scale

  3. stress

    Time frame: baseline-1 year

    visual numeric 0-10 scale

  4. problems sleeping

    Time frame: baseline-1 year

    visual numeric 0-10 scale

  5. depression (PHQ-8)

    Time frame: baseline-1 year

    8 item 0-3 scale

  6. self-efficacy for caregiving

    Time frame: baseline-1 year

    9-item 1-10 scale

  7. caregiver stress

    Time frame: baseline-1 year

    13-item 3 point scale

  8. caregiver burden

    Time frame: baseline-1 year

    12-item 5 point scale

  9. 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

  10. exercise

    Time frame: baseline- 1 year

    number of minutes of exercise in past week

  11. general health

    Time frame: baseline-1 year

    single item scale of overall health

Secondary outcomes

  1. care partner health utilization

    Time frame: baseline- 1 year

    number of MD ER hospital visits for person being cared for in past 6 months

  2. carepartners general health

    Time frame: baseline-1 year

    single item scale of overall health of person being cared for

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2017
First posted
Jul 31, 2014
Registry last updated
Apr 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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