Mobile Phone Support for Adults and Support Persons to Live Well With Diabetes
NCT ID: NCT04347291
Last Updated: 2024-01-17
Study Results
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View full resultsBasic Information
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COMPLETED
NA
638 participants
INTERVENTIONAL
2020-04-28
2023-02-17
Brief Summary
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Detailed Description
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* Monthly coaching sessions (20-30 minutes each) with patient participants by phone focusing on helpful/unhelpful/desired family and friend behaviors relevant to the patients' self-identified diet, exercise, and/or stress management goal
* Daily one-way and interactive text messages to the patient to support him/her in meeting the identified daily goal and medication adherence
* Weekly interactive text messages asking the patient to reflect on goal progress followed by personalized feedback from the coach
* The option to invite an adult support person to receive text messages (3 one-way per week and one interactive text per week) encouraging the support person to discuss the patient's self-care goal to provide opportunities for the patient to practice skills discussed during phone coaching
Participants will be randomized in a parallel design to either FAMS 2.0 or an active control. Our target enrollment is N=334 dyads (patient participants and support persons). Patients are encouraged to invite a support person, but it is not required. Patients and their support person will be randomized together (if enrolled). The study is powered to detect a 0.5% reduction in hemoglobin A1c. Analyses will examine effects at 9 months (post-intervention) and 15 months (sustained effects). The investigators will impute missing data, including all participants completing at least two data collection periods in analyses. Participants will be analyzed as randomized regardless of withdrawal from the intervention (i.e., intention-to-treat principals).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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FAMS 2.0
Patient participants will receive FAMS 2.0 components (monthly phone coaching and text message support for goals and medication adherence) for nine months. Linked support persons will receive text message support tailored to the goal set by the patient participant.
All patient participants will receive text messages advising how to access their study A1c test results, and receive high-quality print materials including a book upon enrollment and quarterly newsletters on healthy living with diabetes. All support person participants will receive high-quality print materials including a book and information about providing quality social support upon enrollment and quarterly newsletters on healthy living with diabetes.
FAMS 2.0
FAMS components include monthly phone coaching following a semi-structured protocol plus daily automated text message support to the patient participant and less frequent automated text messages to their support person, if enrolled.
Print Materials
Quality print materials about diabetes management provided upon enrollment and in quarterly study newsletters.
Print Materials
All patient participants will receive text messages advising how to access their study A1c test results, and receive high-quality print materials including a book upon enrollment and quarterly newsletters on healthy living with diabetes. All support person participants will receive high-quality print materials including a book and information about providing quality social support upon enrollment and quarterly newsletters on healthy living with diabetes.
Print Materials
Quality print materials about diabetes management provided upon enrollment and in quarterly study newsletters.
Interventions
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FAMS 2.0
FAMS components include monthly phone coaching following a semi-structured protocol plus daily automated text message support to the patient participant and less frequent automated text messages to their support person, if enrolled.
Print Materials
Quality print materials about diabetes management provided upon enrollment and in quarterly study newsletters.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Speaks and reads in English
* 18-75 years old
* Diagnosed with type 2 diabetes
* Receiving outpatient care from a partnering clinic
* Community dwelling (e.g., not in a nursing facility)
* Prescribed at least one daily diabetes medication
* Owns a mobile phone
SUPPORT PERSONS:
* Speaks and reads in English
* 18 years or older
* Owns a mobile phone
Exclusion Criteria
* Unable to communicate by phone
* Pregnant currently
* Currently undergoing treatment for cancer (e.g., radiation, chemotherapy)
* Diagnosed with end-stage renal disease
* Receiving hospice services
* Diagnosed with congestive heart failure
* Diagnosed with dementia
* Diagnosed with schizophrenia
* Reported current abuse during screening
* Demonstrates inability to receive and respond to a text
* Does not take medication on his/her own/medication administered by someone else
SUPPORT PERSONS:
\- Demonstrates inability to receive and respond to a text
18 Years
75 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Vanderbilt University Medical Center
OTHER
Responsible Party
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Lindsay Mayberry
Principal Investigator
Locations
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Vanderbilt University Medical Center
Nashville, Tennessee, United States
Countries
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References
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Roddy MK, Spieker AJ, Greevy RA Jr, Nelson LA, Berg C, Mayberry LS. Diabetes-specific family functioning typology associated with intervention engagement and effects: secondary analyses from a randomized controlled trial. Ann Behav Med. 2025 Jan 4;59(1):kaae070. doi: 10.1093/abm/kaae070.
Roddy MK, El-Rifai M, LeStourgeon L, Aikens JE, Wolever RQ, Greevy RA, Mayberry LS. Prerandomization withdrawals from a Type 2 diabetes self-care support intervention trial are associated with lack of available support person coparticipant. Chronic Illn. 2025 Mar;21(1):105-114. doi: 10.1177/17423953231203734. Epub 2023 Sep 26.
Mayberry LS, El-Rifai M, Nelson LA, Parks M, Greevy RA Jr, LeStourgeon L, Molli S, Bergner E, Spieker A, Aikens JE, Wolever RQ. Rationale, design, and recruitment outcomes for the Family/Friend Activation to Motivate Self-care (FAMS) 2.0 randomized controlled trial among adults with type 2 diabetes and their support persons. Contemp Clin Trials. 2022 Nov;122:106956. doi: 10.1016/j.cct.2022.106956. Epub 2022 Oct 5.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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200398
Identifier Type: -
Identifier Source: org_study_id
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