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. 2022 Nov:122:106956.
doi: 10.1016/j.cct.2022.106956. Epub 2022 Oct 5.

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

Lindsay S Mayberry  1 , Merna El-Rifai  2 , Lyndsay A Nelson  2 , Makenzie Parks  2 , Robert A Greevy Jr  3 , Lauren LeStourgeon  2 , Samuel Molli  2 , Erin Bergner  2 , Andrew Spieker  3 , James E Aikens  4 , Ruth Q Wolever  5
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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

Lindsay S Mayberry et al. Contemp Clin Trials. 2022 Nov.

Abstract

Background: Self-care behaviors help reduce hemoglobin A1c (HbA1c) and prevent or delay type 2 diabetes (T2D) complications. Individualized interventions that support goal setting and self-monitoring improve self-care and HbA1c in the short-term; engaging family and friends may enhance and/or sustain effects. Family/Friend Activation to Motivate Self-care (FAMS) is a mobile phone-delivered intervention (i.e., phone coaching and text message support) based on Family Systems Theory which was successfully piloted among diverse adults with T2D.

Methods: We made improvements to FAMS and conducted iterative usability testing to finalize FAMS 2.0 before evaluation in a randomized controlled trial (RCT). Adult persons with diabetes (PWDs) who enrolled were asked to invite a support person (friend or family member) to participate alongside them. For the RCT, dyads were randomly assigned to FAMS 2.0 or enhanced treatment as usual (control) for the first 9 months of the 15-month trial. Outcomes include PWDs' HbA1c and psychosocial well-being (including diabetes distress) and support persons' own diabetes distress and support burden.

Results: We recruited RCT participants from April 2020 through October 2021 (N = 338 PWDs with T2D; 89% [n = 300] with a support person). PWDs were 52% male, 62% non-Hispanic White, aged 56.9 ± 11.0 years with HbA1c 8.7% ± 1.7% at enrollment; 73% cohabitated with their enrolled support person. Data collection is ongoing through January 2023.

Conclusion: Findings will inform the utility of engaging family/friends in self-care behaviors for both PWD and support person outcomes. Using widely available mobile phone technology, FAMS 2.0, if successful, has potential for scalability.

Trial registration: ClinicalTrials.gov identifier: NCT04347291 posted April 15, 2020.

Keywords: Diabetes distress; Family intervention; Glycemic control; Social support; Type 2 diabetes.

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Conflict of interest statement

Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Figures

Figure 1.
Figure 1.. FAMS intervention components mapped onto Family Systems Theory feedback loop.
Additions made to version 2.0 are indicated in bold. Note: A version of this figure has been published in L. S. Mayberry, C. A. Berg, R. A. Greevy, L. A. Nelson, E. M. Bergner, K. A. Wallston, et al. Annals of Behavioral Medicine 2020 Vol. 55 Issue 2 Pages 165–178.
Figure 2
Figure 2. Conceptual Framework for the FAMS 2.0 RCT including PWD and support person intervention targets, outcomes and hypotheses.
Figure 3.
Figure 3.. Recruitment CONSORT flow diagram.
See this image and copyright information in PMC

References

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