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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

Diabetes Mellitus, Type 2Diabetes Mellitus, Type 1Diabetes self management

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

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1 of 30 participants interested
3% interest

See if this study fits

A short prescreen based on this study's listed criteria. A coordinator confirms eligibility — this is not a medical assessment.

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Study locations

Choose your preferred location, or select flexible during enrollment.

RECRUITING

Atlanta

Georgia

Location available

Express your interest

Share your contact details and a study coordinator can follow up about screening.

Secure & Confidential

Your information is protected and will only be shared with the research team.

What participation can include

  • Study-related care provided by the research team
  • Close monitoring by medical professionals
  • Possible compensation for time and travel*
  • The option to withdraw at any time
  • Contributing to medical research that may help future patients

*Compensation varies by study. Confirm details with coordinator.

Typical next steps

  1. 1.Submit this form
  2. 2.Phone screening
  3. 3.In-person assessment if eligible
  4. 4.Begin participation

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Looking for Diabetes Mellitus, Type 2 Treatment in Atlanta?

Join others in Georgia exploring innovative treatment options through clinical research

Diabetes Mellitus, Type 2 Treatment Options in Atlanta, Georgia

If you're searching for Diabetes Mellitus, Type 2 treatment in Atlanta, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Atlanta and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Diabetes Mellitus, Type 2. All study-related care is provided at no cost to participants.

Local Sites
1 locations in Georgia
Now Enrolling
Up to 30 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Diabetes Mellitus, Type 2?

Potential Benefits

  • Access to new treatment approaches before public availability
  • Close monitoring by experienced medical professionals
  • Study-related care provided at no cost
  • Contribute to medical research for Diabetes Mellitus, Type 2

What to Expect

  • Initial screening to determine eligibility
  • Regular check-ups and monitoring visits
  • Possible compensation for time and travel
  • You can withdraw at any time

Frequently Asked Questions About This Diabetes Mellitus, Type 2 Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT07474376. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.