Evaluating the Effectiveness of the Health App Recommendation Tool

NCT07216716 | Recruiting

• 1 other identifier: STUDY25080051
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alzheimers Disease Related Dementias

Keywords

Alzheimer's Disease; Dementia; Dementia Caregivers; Smart Technology; Assistive Technology

Outcome Measures

Primary Outcomes (5)

• World Health Organization Quality of Life (WHOQOL-BREF)

  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.

  Baseline and 4 week follow-up

• 36-Item Short Form Health Survey (SF-36)

  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.

  Baseline and 4 week follow-up

• Patient Health Questionnaire-4 (PHQ-4)

  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.

  Baseline and 4 week follow-up

• Zarit Burden Interview (ZBI)

  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.

  Baseline and 4 week follow-up

• Global Fatigue Index (GFI)

  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.

  Baseline and 4 week follow-up

Secondary Outcomes (1)

• Davis Usability Surveys

  4 week follow-up

Study Arms (1)

HART Use

EXPERIMENTAL

After providing consent, participants will complete baseline surveys via REDCap, followed by a 35-minute virtual onboarding session on Microsoft Teams. During onboarding, participants will learn about the Health App Recommendation Tool (HART) and create a profile. Using an algorithm, HART matches participant needs with health apps, displaying the top three to four recommendations. Study staff will record these apps and provide download guidance. No app data will be shared with the team. Participants may use the apps as they choose over a four-week period. Afterward, follow-up assessments will be sent via REDCap, including WHOQoL, SF-36, PHQ-4, ZBI, Global Fatigue Index, and Davis Usability Surveys. Both baseline and follow-up surveys take about 35 minutes to complete.

Other: Health App Recommendation Tool (HART)

Interventions

Health App Recommendation Tool (HART) OTHER

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.

HART Use

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15203, United States

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease; Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Julie M Faieta, PhD, MOT

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julie M Faieta, PhD, MOT

CONTACT

412-648-7792; juf52@pitt.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 10, 2025
• First Posted: October 15, 2025
• Study Start: December 5, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: January 9, 2026

Record last verified: 2026-01

Locations

US (1)