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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:
Multimorbidity, defined as the presence of two or more chronic health conditions, is increasingly common among adults aging with long-term illnesses. Diabetes is one of the most prevalent chronic conditions contributing to multimorbidity and is associated with a wide range of complications, including cardiovascular disease, kidney disease, neuropathy, mental health symptoms, and functional decline. Many individuals with diabetes also live with additional chronic conditions such as hypertension, arthritis, or mood disorders, which together create complex care needs and daily symptom challenges. Although multimorbidity is known to increase healthcare utilization, costs, and burden on individuals and caregivers, the specific patterns, trajectories, and risk factors associated with diabetes-related multimorbidity remain insufficiently understood.
Existing research has described multimorbidity using cross-sectional clustering, network analysis, and other data-driven methods. More recent studies have used longitudinal modeling, disease-transition analyses, and machine-learning approaches to examine how chronic conditions develop and progress over time. However, these studies have largely relied on secondary data sources such as electronic health records or insurance claims. As a result, they provide limited insight into the lived experience of individuals managing multiple chronic conditions, the daily symptoms they encounter, and the strategies they use to regulate their health and functioning. There is also limited evidence on how multimorbidity typologies and trajectories specifically manifest in people with diabetes, or how social, behavioral, and contextual factors influence these patterns.
Self-management plays a central role in diabetes care, yet many individuals with diabetes and multimorbidity report feeling insufficiently involved in clinical decision-making or goal setting. Daily self-regulation strategies-such as prioritizing tasks, optimizing available resources, and compensating for limitations-may help individuals manage symptoms and maintain quality of life. These strategies can be influenced by pain, fatigue, sleep disturbance, mood symptoms, cognitive changes, and communication with healthcare providers. Understanding how individuals use these strategies in real-world settings may help identify opportunities to support more effective and personalized self-management.
Audio diaries offer a promising method for capturing real-time experiences, reflections, and self-management behaviors. Compared with written diaries, audio diaries may be easier for older adults to use and can capture additional information such as tone, pauses, and emotional expression. Early work with audio-based tools suggests they may support self-reflection and provide insight into physical, emotional, and social well-being. However, the feasibility, usability, and acceptability of audio diaries among older adults with diabetes and multimorbidity have not been fully evaluated.
This study aims to address these gaps by examining diabetes-related multimorbidity typologies, trajectories, and associated risks using advanced analytic methods, and by exploring daily self-management through an adapted audio diary mobile application. Guided by a self-regulation framework, the study will assess the feasibility of using an audio diary tool to document daily experiences, symptom patterns, and self-regulation strategies among adults living with diabetes and multiple chronic conditions. The study will also explore how audio diary data may inform future interventions designed to support self-management and improve quality of life.
The findings from this study are expected to contribute to a better understanding of how multimorbidity develops and progresses in individuals with diabetes, how daily symptoms and self-management strategies interact, and how audio-based tools may be used to support ongoing care. This work will lay the foundation for future longitudinal and intervention studies aimed at improving health outcomes for individuals aging with multiple chronic conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wenhui Zhang, PhD | Contact | 762-499-0411 | wenhui.zhang@emory.edu |
| Name | Affiliation | Role |
|---|---|---|
| Wenhui Zhang, PhD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory Healthcare | Recruiting | Atlanta | Georgia | 30329 | United States |
All of the individual participant data collected during the trial, after deidentification, except the audio diary data will be shared.
Beginning 9 months and ending 36 months following article publication.
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.
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| 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 |
| Day 1, Day 7, 1 month, 3 months. |
| 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." | Day 1, Day 7, 1 month, 3 months. |
| Healthcare Utilization: Cost | Costs that are paid out-of-pocket for participant (or family) healthcare (including deductibles, co-pays, and uncovered services). | Day 1, Day 7, 1 month, 3 months. |
| 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. | Day 1, Day 7, 1 month, 3 months |
| Instrumental Activities of Daily Living (Lawton IADL Scale) | Assesses independence in eight higher-level daily tasks: telephone use, shopping, food preparation, housekeeping, laundry, transportation, medication management, and handling finances. Each domain is scored as 1 (independent) or 0 (dependent). As stated in the form, scores range from 0-8 for women and 0-5 for men to avoid gender bias. Higher scores indicate greater functional independence. | Day 1-7; Day 7-1 or 3 months |
| Katz Index of Independence in Activities of Daily Living | Evaluates basic physical functioning across six domains: bathing, dressing, toileting, transferring, continence, and feeding. Each activity is scored 1 = independent or 0 = dependent based on the descriptions in the form, such as "Bathes self completely…" versus "Needs help with bathing more than one part of the body." Total scores range from 0 (very dependent) to 6 (fully independent), with higher scores indicating greater independence in essential daily activities. | Day 1-7; Day 7-1 or 3 months |
| Patient-Health Care Provider Communication Scale scores | Evaluates the quality of communication between patients and their healthcare providers using 18 provider-focused items and 3 patient-focused items. Domains include answering questions, understanding patient concerns, providing explanations, presenting treatment options, showing respect and patience, and communicating the patient's comfort. Items are rated from 1 ("Not at all like") to 4 ("Very much like"), such as "Answers my questions about my health" and "Feel comfortable telling my health care provider about my health concerns." Higher scores reflect better communication quality. | Day 1, Day 7, 1 month, 3 months |
| Brief Health Literacy Screening | Evaluates frequencies in reading, learning, and understanding about health information with items such as, "How often do you have a problem understanding what is told to you about your medical condition?" and confidence to fill out medical forms by themselves. Higher total scores indicate higher health literacy. Responses of the 4 items were scaled from 1 (always/not at all confident) to 5 (never/extremely confident) with a total score ranging from 4 to 20 (4-12: inadequate, 13-16 marginal adequate, 17-20 adequate). Higher scores indicate higher health literacy levels | Day 1, Day 7, 1 month, 3 months |
| Lubben Social Network Scale | Evaluates the social network regarding number of relatives and friends available for help and support. Participants rate the score of their experiences in the last six months regarding items such as "How many relatives do you see or hear from at least once a month?" Responses of the six items are scaled from 0 (none) to 5 (nine or more). Higher total scores indicate higher support, and the total score ranges from 0 to 30. Higher scores reflect better social network. | Day 1, Day 7, 1 month, 3 months |
| Selection, Optimization, and Compensation Questionnaire | Evaluates the selection, optimization and compensation strategy applications in daily lives. It includes four parts - elective-based selection, loss-based selection, optimization, and compensation. Participants rated the items considering their healthy lifestyles in the last six months such as "When I think about what I want in life, I commit myself to one or two important goals". Examples such as "(e.g., Commitment to leisure or health purposes)" from prior arthritis and MCCs studies were provided. When responding to the questionnaire items, participants rated their frequencies of using such strategies from 1 (Never) to 5 (Always). Higher scores indicate more strategy use | Day 1, Day 7, 1 month, 3 months |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |