Comparative Effectiveness of Family vs. Individually Focused Diabetes Education and Support

  • STATUS
    Recruiting
  • End date
    May 31, 2024
  • participants needed
    536
  • sponsor
    University of Pittsburgh
Updated on 7 October 2022
diabetes

Summary

The objective of this study is to compare the effectiveness of a novel program-Family Support for Health Action (FAM-ACT) - to individual patient-focused diabetes self-management education and support (I-DSMES).

Description

FAM-ACT uses three innovative approaches to enhance the impact of family support on diabetes management for adults with diabetes (AWDs):

  1. coach family supporters in regular discussions about AWDs' diabetes progress and goals that uses empathetic and autonomy-supportive communication,
  2. coach family supporters in practical roles that support diabetes-specific tasks tailored to AWDs' personal goals,
  3. leverage family support in the setting of other types of social support for AWDs (support from other AWDs and their family members and Community Health Workers (CHWs))

FAM-ACT will be developed and implemented in culturally-concordant ways, in partnership with the community participating in the program.

Adults with type 2 diabetes and either poor glycemic or blood pressure control will be randomized together with a Support Person (a chosen adult family member or friend) to receive either FAM-ACT or more traditional CHW-led patient-focused I-DSMES over 6 months.

CHWs will deliver FAM-ACT through Dyadic (Patient-Support Person) focused group DSME sessions plus Dyadic-focused care management sessions to Patient-Support Person dyads at an urban federally qualified health center. When situationally appropriate, the care management sessions will be conducted by phone/video call or using a HIPAA-compliant online video-conferencing platform.

Details
Condition Diabetes Mellitus, High Blood Pressure, High Blood Sugar, Hypertension
Treatment FAM ACT, I-DSME+CM, I-DSMES
Clinical Study IdentifierNCT03812614
SponsorUniversity of Pittsburgh
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Able to attend intervention sessions in person or remotely via online video-conferencing
At least 21 years old

Exclusion Criteria

Does not speak English or Spanish
Receives pay for caring for the patient
Has self-reported serious mental illness (schizophrenia)
Has a life-limiting severe illness (e.g. chronic obstructive pulmonary disease requiring oxygen)
Has significant cognitive impairment (Alzheimer's disease or dementia)
Lives in a nursing home or long-term care facility
Concerns that may make it difficult to participate (ongoing health issues, personal events, etc.)
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Step 1 Connect with a study center
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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