Evaluating the Effectiveness of the Health App Reccommendation Tool

Not Applicable

Not yet recruiting

• Conditions: Alzheimers Disease Related Dementias

• Registration Number: NCT07216716
• Lead Sponsor: University of Pittsburgh

Brief Summary

This study aims to assess the effectiveness of the Health App Recommendation Tool (HART), an evidence-based tool that evaluates app features, then matches these features 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 an app is for a member of the ADRD or caregiver population. Specifically, the objective of this research is to assess acceptability of current HART design to the target end-user in their individual context. The goal of this project is to connect those in the ADRD community with available, usable, and effective tools to ensure the highest level of health and wellness in the community setting.

To achieve this goal, this study will recruit 15 family caregivers living with their loved ones with ADRD, who will trial the HART and provide feedback. Participation will include two data collection sessions (pre-intervention and post-intervention) within 4-week trial period. Participants will be asked to complete the HART, explore the recommended apps, and provide your thoughts on HART's usability via several brief surveys.

Detailed Description

Dementia caregiving is a growing challenge predominantly shouldered by young and middle-aged adults, who often face significant physical and mental health needs. Despite the availability of numerous smart health technologies capable of addressing these needs, caregivers frequently encounter difficulties in identifying appropriate health applications due to the overwhelming number of options and lack of clear guidance.

Proposed Solution: To bridge this gap, the Health App Recommendation Tool (HART) has been developed as a user-friendly platform designed to connect dementia caregivers with biomedical health apps tailored to their individual requirements.

The HART operates by gathering targeted information from users regarding their specific needs, accessibility considerations, available supports, and technology literacy through a brief intake survey. A sophisticated matching algorithm then evaluates these user profiles against a library of health apps that have been objectively reviewed, providing a curated list of the most suitable applications for each caregiver. This personalized approach aims to facilitate the adoption and sustained use of health apps, thereby enhancing caregivers' health and quality of life.

Preliminary evaluations indicate that HART holds promise in setting a new standard in personalized health technology, offering a practical solution for dementia caregivers navigating the extensive and uncharted landscape of biomedical health applications that address their individual and multifaceted needs. By simplifying the process of finding suitable health technologies, HART not only alleviates the burden on caregivers but also empowers them to manage their own health and caregiving responsibilities more effectively. The ongoing refinement and evaluation of HART are crucial to ensuring its effectiveness and widespread adoption, ultimately contributing to improved health outcomes for dementia caregivers and their care recipients.

Objectives. Objective 1. Complete initial trial of HART to determine effectiveness in alleviating dementia caregiver stress.

To achieve this objective, a series of preliminary N-of-one trials with 15 dementia caregivers will be used to examine patterns of health app use and their influence on health and quality of life outcomes over a four-week period.

Participants will be recruited through Pitt+Me, the University of Pittsburgh Pepper registry, other applicable registries, and existing relationships with local dementia caregiver community organizations. Health and quality of life measures be completed at baseline and immediately following 4 week intervention. Participants will complete the Health App Review Tool user profile to determine their top recommended health apps. Study team members will be available to answer questions and to assist in downloading the Health App Review Tool recommended health apps as needed. Participants will then utilize these recommended apps in their individual, routine community settings across a period of four weeks. Following app utilization, baseline measures will be repeated.

Objective 2. Refine HART interface and functionality based on feedback from initial effectiveness trial. Our team of clinicians and engineers will review qualitative and quantitative feedback from the initial effectiveness trial (see Objective 1) and determine any function or interface refinements needed in preparation for larger effectiveness trials and subsequent commercialization.

Study Timeline

• Status Verified: 2025-10
• Study First Submitted: 2025-10-10
• Study First Submitted QC: 2025-10-10
• Last Update Submitted: 2025-10-10
• Study First Posted: 2025-10-15
• Last Update Posted: 2025-10-15
• Study Start: 2025-11-01
• Primary Completion: 2026-06-30
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Aged between 18 to 65
• Serving as active caregivers for their loved one with Alzheimer's Disease and Related Dementia
• Have access to smart devices such as smartphones, smart tablets, smart watches, etc.

Exclusion Criteria

• Individuals with Alzheimer's Disease or Related Dementia, or with severe cognitive decline, will be excluded
• Participants who do not provide caregiving routinely (part-time or secondary caregiver) will be excluded
• Participants who do not own or have access to any Smart device will be excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
World Health Organization Quality of Life (WHOQOL-BREF)	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)	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)	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)	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)	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.

Secondary Outcome Measures

Name	Time	Method
Davis Usability Surveys	4 week follow-up	The Davis Usability Survey, based on the Technology Acceptance Model (TAM), evaluates several constructs that impact technology adoption: Perceived Usefulness (PU), Perceived Ease of Use (PEOU), and Attitudes Towards Use (ATU). Each subscale contians 7, 10, and 6 items respectively rated on a 5-point Likert scale, with higher values indicating more favorable perceptions of usability and acceptance. Subscale scores are calculated by averaging the items within each domain.

Trial Locations

Locations (1)

Univeristy of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States