NCT07474376 · Emory University
Diabetes Multimorbidity Typology, Trajectory, and Feasibility of an Audio Diary Mobile Application to Support Self-management
What this study is about
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.
View original scientific description
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.
Interventions
OTHER
Fabla Mobile App
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
Primary outcome measures
Feasibility of the Audio Diary Mobile App
Time frame: Day 1-7; Day 7-1 or 3 months
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.
Expressiveness
Time frame: Day 1-7; Day 7-1 or 3 months
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.
Acceptability, Appropriateness, and Feasibility Measures
Time frame: Day 1-7; Day 7-1 or 3 months
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.
System Usability Scale
Time frame: Day 1-7; Day 7-1 or 3 months
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
Rates of interest
Time frame: Screening
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.
Rates of eligibility
Time frame: Screening
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.
Rates of completion
Time frame: Day 1; Day 1-7; Day 7; Day 7-1 or 3 months; 1 month; 3 months
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.
Linguistic Inquiry and Word Count (LIWC) analysis of the audio diaries
Time frame: Day 1-7; Day 7-1 or 3 months
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- •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.
Where
- Atlanta, Georgia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 4, 2026 · Source of record for eligibility and locations