NCT07216716 · University of Pittsburgh
Evaluating the Effectiveness of the Health App Recommendation Tool
(HART)
What this study is about
This study aims to assess the effectiveness of the Health App Recommendation Tool (HART), an evidence-based tool that evaluates app features and matches them to the needs, abilities, and preferences of individuals with Alzheimer's disease and related dementias (ADRD) or their caregivers.
View original scientific description
This study aims to assess the effectiveness of the Health App Recommendation Tool (HART), an evidence-based tool that evaluates app features and matches them to the needs, abilities, and preferences of individuals with Alzheimer's disease and related dementias (ADRD) or their caregivers. This novel tool is not an app in and of itself, but rather an assessment tool used to determine how well suited a given app is for a member of the ADRD or caregiver population. Specifically, the objective of this research is to assess the acceptability of the current HART design among target end-users in their individual contexts. The overarching goal of this project is to connect those in the ADRD community with available, usable, and effective digital tools to promote the highest possible level of health and wellness in community settings. To achieve this goal, the study will recruit 15 family caregivers living with their loved ones with ADRD, who will trial HART and provide feedback. Participation will include two data collection sessions (pre-intervention and post-intervention) within a four-week trial period. Participants will be asked to complete the HART, explore the recommended apps, and provide feedback on HART's usability through several brief surveys.
Interventions
OTHER
Health App Recommendation Tool (HART)
In 2023, over 11 million family members provided 19.2 billion hours of unpaid care for people with dementia in the U.S. Caregivers face significant physical and emotional challenges, while many individuals with ADRD prefer to stay in their homes. Mobile health apps offer support but often lack user-friendly guidance and are hard to navigate. The Health App Recommendation Tool (HART) bridges this gap by assisting ADRD caregivers in finding suitable health apps. It evaluates users' daily needs and preferences, using end-user informed points of measurement to match them with objectively reviewed apps within the HART App Library. This user-centered tool, shaped by ongoing feedback, simplifies app discovery, ensuring personalized recommendations that enhance caregiving and improve quality of life.
Primary outcome measures
World Health Organization Quality of Life (WHOQOL-BREF)
Time frame: Baseline and 4 week follow-up
The WHOQOL-BREF, developed by the World Health Organization, is a measure of perceived quality of life. It includes 26 items across Physical Health, Psychological, Social Relationships, and Environment domains, along with two stand-alone global items assessing overall quality of life and health. Each domain score is transformed to a 0-100 scale, with higher scores indicative of a better quality of life.
36-Item Short Form Health Survey (SF-36)
Time frame: Baseline and 4 week follow-up
The SF-36 is a widely used measure of health-related quality of life that captures eight dimensions: Physical Functioning, Role Limitations due to Physical Health, Bodily Pain, General Health, Vitality, Social Functioning, Role Limitations due to Emotional Problems, and Mental Health. All items are scored from 0 to 100, with higher scores indicative of better health status. Scale scores are produced by averaging scores across items in that respective scale.
Patient Health Questionnaire-4 (PHQ-4)
Time frame: Baseline and 4 week follow-up
The PHQ-4 is an brief screening tool designed to assess anxiety and depressive symptoms over the past two weeks. It contains four items, each rated from 0 ("not at all") to 3 ("nearly every day"). Subscale scores for anxiety and depression range from 0-6 each, and the total score ranges from 0-12, with higher scores indicating greater psychological distress. Total scores of 0-2 suggest no distress, 3-5 mild, 6-8 moderate, and 9-12 severe distress.
Zarit Burden Interview (ZBI)
Time frame: Baseline and 4 week follow-up
The Zarit Burden Interview assesses the level of burden experienced by informal caregivers. The 22 items are rated on a 5-point Likert scale from 0 ("never") to 4 ("nearly always"), yielding a total score ranging from 0 to 88. Higher scores indicate greater perceived caregiver burden. Typical interpretive ranges classify scores of 0-21 as little or no burden, 21-40 as mild to moderate burden, 41-60 as moderate to severe burden, and 61-88 as severe burden.
Global Fatigue Index (GFI)
Time frame: Baseline and 4 week follow-up
The Global Fatigue Index is composite measure of fatigue severity and impact. It integrates ratings of fatigue intensity, distress, timing, and interference with daily activities, all on a 1-10 scale, and the final frequency question on a scale of 0-4. Higher total scores indicate greater fatigue.
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
- Aged between 18 and 65
- Serving as an active caregiver for a loved one with Alzheimer's disease or a related dementia
- Have access to smart devices such as smartphones, tablets, or smartwatches
Exclusion criteria
- Individuals with Alzheimer's disease or a related dementia, or with severe cognitive decline, will be excluded
- Participants who do not provide caregiving on a routine basis (e.g., part-time or secondary caregivers) will be excluded
- Participants who do not own or have access to any smart device will be excluded
Where
- Pittsburgh, Pennsylvania
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 Jan 9, 2026 · Source of record for eligibility and locations