Diabetes Multimorbidity Typology, Trajectory, and Feasibility of an Audio Diary Mobile Application to Support Self-management

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorEmory University

About this trial

The goal of this clinical trial is to evaluate whether an audio diary mobile application (Fabla-diabetesMM) is feasible to use and may support self-management in older adults with type 1 or 2 diabetes and multimorbidity.

The main questions it aims to answer are:

* Is it feasible to adapt and implement the Fabla-diabetesMM audio diary mobile app among 30 older adults with diabetes and multimorbidity * Does the use of the audio diary mobile app affect self-management outcomes

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosed type 1 or 2 diabetes and at least one comorbidity (eg, obesity, HIV, heart failure, polycystic ovary syndrome, obstructive sleep apnea, and prediabetes with and without hypertension)

Being able to fill in the Redcap surveys, and install and use the audio diary app.

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • Fabla Mobile App

    Other intervention

    Participants will use an adapted audio diary mobile application (Fabla-diabetesMM) designed to collect daily structured and semi-structured audio reflections on health conditions, symptoms, self-management strategies, goal attainment, and feasibility feedback. The app is tailored for older adults, including adjustments to interface, font, navigation, and question wording. Intervention Components: * Daily audio diary entries for 7 days, with optional continued use up to 1 or 3 months * Structured survey items integrated into the app (e.g., symptoms, self-regulation, self-efficacy, healthcare use) * Semi-structured audio prompts about daily experiences, self-management, and health changes * Reminder notifications to encourage diary completion * Video instructions on how to use the app

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Single-Arm Feasibility InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility of the Audio Diary Mobile App

Feasibility will be assessed through feedback from clinicians or researcher experts, and participants with interviews and feasibility question replies in the audio diary mobile application. Semi-structured interviews (30-45 minutes) will probe experiences with filling in the RedCap survey and using the mobile app (e.g., design, navigation, structure, and language). Interviews and field notes will capture participants' interactions with the survey and mobile app and document problems using them. With a final version that will be used in the clinical trial, participants will be asked to use the app and respond to questions such as "Please talk more about the acceptability, appropriateness and feasibility of this audio diary mobile app" or "Please discuss the acceptability, appropriateness, feasibility, and usability of this audio diary mobile app based on the question above. For example, the likes and dislikes about the app." More positive feedback indicates greater feasibility.

Time frame
Day 1-7; Day 7-1 or 3 months
2

Expressiveness

A 5-item manipulation check questionnaire adapted from Pennebaker and Beall (1986) was used to assess participants' perceptions of expressiveness levels with the audio diary task condition to which they were assigned. On a Likert scale, ranging from 1=not at all to 7=a great deal, participants were asked to respond to items such as "How personal was your essay today?" and "To what degree did you reveal your emotions in your essay?" (total score from 5 to 35). Higher expressiveness scores indicate more expressiveness and greater feasibility.

Time frame
Day 1-7; Day 7-1 or 3 months
3

Acceptability, Appropriateness, and Feasibility Measures

A 12-iteminstrument that consists of three distinct four-item scales used to evaluate implementation acceptability, appropriateness, and feasibility. On a Likert scale, ranging from 1=completely disagree to 5=completely agree, participants were asked to respond to items such as "This audio diary mobile app is appealing to me" for acceptability, "This audio diary mobile app seems fitting" for appropriateness or "This audio diary mobile app seems possible for feasibility. Higher measure scores indicate greater acceptability, appropriateness, and feasibility.

Time frame
Day 1-7; Day 7-1 or 3 months
4

System Usability Scale

The System Usability Scale (SUS) is a standardized, 10-item questionnaire used to measure the perceived usability of a product, system, or service. Each item is rated on a 5-point Likert scale ranging from Strongly disagree to Strongly agree. Participants were asked to respond to items such as "I think that I would like to use this app frequently." Higher scale scores indicate greater usability

Time frame
Day 1-7; Day 7-1 or 3 months

Secondary outcomes

1

PROMIS Self-Efficacy Scores

Measures confidence in managing health and daily life across multiple domains, including general self-efficacy, managing medications and treatment, managing symptoms, managing daily activities, managing social interactions, and managing emotions. Items use a 1-5 scale ("I am not at all confident" to "I am very confident"), such as "I can manage to solve difficult problems if I try hard enough" and "I can handle whatever comes my way." Higher scores indicate greater self-efficacy.

Time frame
Day 1, Day 7, 1 month, 3 months.
2

Healthcare Utilization: Number of services

Measures the number of healthcare service uses, including clinician visits, home health visits, hospitalizations, emergency room visits, prescriptions filled, acupuncture, massage, mind-body therapies (e.g., relaxation therapy), and movement therapies (e.g., Yoga, Tai Chi) with responses including "Yes" or "No", times, and a 4-litem Likert scale from "Never/Rarely" to "Always."

Time frame
Day 1, Day 7, 1 month, 3 months.
3

Healthcare Utilization: Cost

Costs that are paid out-of-pocket for participant (or family) healthcare (including deductibles, co-pays, and uncovered services).

Time frame
Day 1, Day 7, 1 month, 3 months.
4

Quality of life: Visual Analog Scale

Self-reported quality of life using a Visual Analog Scale (0-100 scale). Higher scores indicate better quality of life.

Time frame
Day 1, Day 7, 1 month, 3 months

Other outcomes

Sponsors and contacts

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