E-Tailored Pain Management Support for Dementia Family Caregivers: Feasibility of the PACE-app

Part of paid clinical trials in Iowa City, Iowa.

Sponsor
University of Iowa
Study ID
NCT07032350
Status
Recruiting
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Conditions

  • Care Giving Burden
  • Chronic Pain
  • Dementia
  • Pain Management
  • Palliative Care

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Accepted

Interventions

  • Web-based pain management support tool — OTHER
    The Pain Control Enhancement App (PACE-app) is a web-based tool designed to help family caregivers manage pain in persons with dementia. The app provides a brief screening to identify caregiver challenges and delivers tailored strategies, communication prompts for providers, and an educational resource library. It includes a digital pain diary for tracking daily pain, treatments, and urgent care use, with weekly reports that can be shared with healthcare providers. The app is accessible on any internet-connected device and designed for caregivers with varying levels of digital literacy.
  • Usual Pain Management Care — BEHAVIORAL
    Caregivers receive no new intervention; they manage their care recipient's pain according to standard practices. No access to the PACE-app is given during the study period.

Study Details

The goal of this clinical trial is to test whether a web-based application called the Pain Control Enhancement App (PACE-app) can support family caregivers in managing pain for their care recipients with dementia. The main questions it aims to answer are: Is it feasible and acceptable for family caregivers to use the PACE-app? Does using the PACE-app improve caregiver self-efficacy in pain management, adherence to pain treatments, communication with care providers, well-being, and their care recipient's pain conditions? Researchers will compare caregivers who use the PACE-app to those who continue with their usual care practices to see if the app leads to better outcomes for both caregivers and care recipients. Participants will: Be randomly assigned to either the PACE-app group or a usual-care control group Complete online surveys at baseline, 1 month, and 2 months If assigned to the PACE-app group: Use the PACE-app for 1 month to receive tailored pain management strategies and tools, and record their care recipient's pain in a digital diary Participate in an interview about their experience with the app All participation activities can be done remotely or in person.

Key Dates

Start date
May 22, 2025
Status verified
Jun 2025
Primary completion
May 31, 2026
Completion
May 31, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Active Comparator: Usual Care Group
    Care recipients will continue receiving their regular pain care. Caregivers will complete outcome assessments only. Introductory Meeting (Baseline): Caregivers will attend a 1.5-hour meeting to complete informed consent and baseline REDCap surveys. Follow-up (Month 1 and Month 2): At 1-month and 2-month follow-ups, caregivers will independently complete REDCap surveys (\~45 minutes per follow-up).
  • Experimental: App Use Group
    Care recipients will continue receiving their regular pain care. Caregivers will use the PACE-app and complete outcome assessments. Introductory Meeting (Baseline): Caregivers will attend a 1.5-hour meeting to complete informed consent and baseline REDCap surveys. Intervention Period (Month 1): Caregivers will use the PACE-app for 1 month, complete a daily pain diary (5-10 minutes/day), and access weekly summary reports to share with providers. Post-Intervention (Month 1): Caregivers will complete REDCap surveys and participate in a 1.5-hour interview on their experience with the app (audio-recorded unless declined). Follow-up (Month 2): Caregivers will complete the same REDCap questionnaires to assess longer-term outcomes.

Primary Outcome Measure

Caregiver Self-Efficacy in Pain Management [ Time Frame: Change from baseline to 1 month and 2 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
College of NursingIowa CityIowa52246
Nai-Ching Chi, PhD, MS, MSN, BSN
[email protected]
319-335-7064
Gabriel M Vald, MS, BA
[email protected]
515-897-8517
Nai-Ching Chi, PhD, MS, MSN, BSN (PRINCIPAL_INVESTIGATOR)

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By research site
College of Nursing· Iowa City, IA

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