Evidence map›Paper›PMID 36208719›Full record

ArticleContemporary clinical trials2022

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, Merna El-Rifai, Lyndsay A Nelson, Makenzie Parks, Robert A Greevy, Lauren LeStourgeon, Samuel Molli, Erin Bergner, Andrew Spieker, James E Aikens and 1 more

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in Contemporary clinical trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04347291 (Mobile Phone Support for Adults and Support Persons to Live Well With Diabetes), which is not on this map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04347291 nacompletednot on this map

Mobile Phone Support for Adults and Support Persons to Live Well With Diabetes

TypeinterventionalSponsorVanderbilt University Medical CenterRan2020 to 2023Enrolled638ConditionsType 2 DiabetesArmsFAMS 2.0, Print Materials
3 · Its place in the literature

Who cites it

11 citing papers in PubMed.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Lindsay S MayberryDepartment of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA; Center for Health Behavior and Health Education, Vanderbilt University Medical Center, Nashville, TN, USA; Department of Biomedical Informatics, Vanderbilt University Medical Center, Nashville, TN, USA. Electronic address: lindsay.mayberry@vumc.org.
Merna El-RifaiDepartment of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA; Center for Health Behavior and Health Education, Vanderbilt University Medical Center, Nashville, TN, USA.
Lyndsay A NelsonDepartment of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA; Center for Health Behavior and Health Education, Vanderbilt University Medical Center, Nashville, TN, USA.
Makenzie ParksDepartment of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA; Center for Health Behavior and Health Education, Vanderbilt University Medical Center, Nashville, TN, USA.
Robert A GreevyDepartment of Biostatistics, Vanderbilt University Medical Center, Nashville, TN, USA.
Lauren LeStourgeonDepartment of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA; Center for Health Behavior and Health Education, Vanderbilt University Medical Center, Nashville, TN, USA.
Samuel MolliDepartment of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA; Center for Health Behavior and Health Education, Vanderbilt University Medical Center, Nashville, TN, USA.
Erin BergnerDepartment of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA; Center for Health Behavior and Health Education, Vanderbilt University Medical Center, Nashville, TN, USA.
Andrew SpiekerDepartment of Biostatistics, Vanderbilt University Medical Center, Nashville, TN, USA.
James E AikensDepartment of Family Medicine, University of Michigan, Ann Arbor, MI, USA.
Ruth Q WoleverDepartment of Physical Medicine and Rehabilitation, Vanderbilt University Medical Center, Nashville, TN, USA; Osher Center for Integrative Health at Vanderbilt, Vanderbilt University Medical Center, Nashville, TN, USA.

Funding

Mobile Phone Support for Adults and Support Persons to Live Well with DiabetesR01DK119282 · NIDDK · VANDERBILT UNIVERSITY MEDICAL CENTER · PI MAYBERRY, LINDSAY S. · 2019 to 2022
$2.7M
NIDDK NIH HHS R01 DK119282
6 · The paper itself

Abstract

backgroundSelf-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.

methodsWe 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.

resultsWe 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.

conclusionFindings 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 registrationClinicalTrials.gov identifier: NCT04347291 posted April 15, 2020.

Indexed as

Cell PhoneDiabetes Mellitus, Type 2Text MessagingAdultFemaleGlycated HemoglobinHumansMaleRandomized Controlled Trials as TopicSelf CareGlycated HemoglobinDiabetes distressFamily interventionGlycemic controlSocial supportType 2 diabetes

Identifiers

PMID36208719
PMCPMC10364455

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.