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Building Better Caregivers: Development and Evaluation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02205671
Recruitment Status : Completed
First Posted : July 31, 2014
Last Update Posted : April 25, 2017
Sponsor:
Information provided by (Responsible Party):
Kate Lorig, Stanford University

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


Condition or disease Intervention/treatment Phase
Providing Care for People With Memory Problems Behavioral: Building Better Caregivers Small-group Workshop Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 128 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Building Better Caregivers: Development and Evaluation
Actual Study Start Date : August 2014
Actual Primary Completion Date : July 2015
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

Arm Intervention/treatment
Experimental: Intervention
Building Better Caregivers Small-group Workshop
Behavioral: Building Better Caregivers Small-group Workshop



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02205671


Locations
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United States, California
Stanford University School of Medicine
Stanford, California, United States, 94304
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Kate Lorig, DRPH Stanford School of Medicine
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Responsible Party: Kate Lorig, Professor Emeritus, Stanford University
ClinicalTrials.gov Identifier: NCT02205671    
Other Study ID Numbers: 29894
First Posted: July 31, 2014    Key Record Dates
Last Update Posted: April 25, 2017
Last Verified: April 2017
Keywords provided by Kate Lorig, Stanford University:
caregiving
chronic illness
patient education
self management