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

NCT07474376 | Not Yet Recruiting

• 1 other identifier: 2025P013568
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1

Keywords

Diabetes self management

Outcome Measures

Primary Outcomes (8)

• 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.

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

• 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.

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

• 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.

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

• 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

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

• Rates of interest

  The rate of the number of people who contacted and showed interest in the study will help assess the feasibility of the study. Higher rates of interest indicate greater feasibility.

  Screening

• Rates of eligibility

  The rates of the number of people who completed the screening and were eligible will help understand the feasibility of the study. Higher rates of eligibility indicate greater feasibility.

  Screening

• Rates of completion

  The rates of the number of people who participated the study and completed each tasks will help understand the feasibility of the study. Higher rates of completion indicate greater feasibility.

  Day 1; Day 1-7; Day 7; Day 7-1 or 3 months; 1 month; 3 months

• Linguistic Inquiry and Word Count (LIWC) analysis of the audio diaries

  The LIWC program will evaluate and generate reports on the linguistic inquiry and word counts of the audio diary text. Higher word counts indicate greater feasibility.

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

Secondary Outcomes (10)

• PROMIS Self-Efficacy Scores

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

• Healthcare Utilization: Number of services

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

• Healthcare Utilization: Cost

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

• Quality of life: Visual Analog Scale

  Day 1, Day 7, 1 month, 3 months

• Instrumental Activities of Daily Living (Lawton IADL Scale)

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

Study Arms (1)

Single-Arm Feasibility Intervention

EXPERIMENTAL

Participants are older adults (≥65 years) with type 1 or type 2 diabetes and at least one comorbidity. All participants receive the adapted Fabla-diabetesMM audio diary mobile application and complete structured surveys and audio diary entries over 7 days and up to 1-3 months.

Other: Fabla Mobile App

Interventions

Fabla Mobile App OTHER

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

Single-Arm Feasibility Intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Those who cannot use (e.g., no mobile phone, incompatible system), read, type, speak, or understand English in Redcap or the audio diary mobile app.

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Emory Healthcare

Atlanta, Georgia, 30329, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Wenhui Zhang, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenhui Zhang, PhD

CONTACT

762-499-0411; wenhui.zhang@emory.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 11, 2026
• First Posted: March 16, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Beginning 9 months and ending 36 months following article publication.
• Access Criteria: Proposals may be submitted up to 36 months following article publication. After 36 months, the data will be available in the institution's data warehouse, but without investigator support other than deposited metadata.

Locations

US (1)