E-Tailored Pain Management Support for Dementia Family Caregivers: Feasibility of the PACE-app
NCT ID: NCT07032350
Last Updated: 2025-06-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2025-05-22
2026-05-31
Brief Summary
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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.
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Detailed Description
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Uncontrolled pain is common in people with dementia and presents unique challenges for caregivers, particularly those with limited access to specialized healthcare services. Family caregivers often lack adequate knowledge, skills, and support to manage pain effectively, contributing to suboptimal outcomes for both caregivers and care recipients.
The PACE-app provides tailored, technology-based pain management support that includes:
Screening of caregiver-specific challenges in pain management;
Personalized pain management strategies based on the screening results;
Communication tools to facilitate interactions with healthcare providers;
A digital pain diary for tracking care recipients' pain experiences.
A total of 60 family caregivers of people with dementia and chronic pain will be randomized 1:1 to either the PACE-app intervention group or a usual-care control group. Participants in the intervention arm will use the app for 1 month and complete outcome assessments at baseline, 1 month (post-intervention), and 2 months (follow-up). Participants in the control arm will continue their usual caregiving practices and complete assessments on the same schedule.
Primary outcomes include feasibility (recruitment, retention, adherence to study protocol) and acceptability (measured by app usage analytics and qualitative interviews). Secondary outcomes include changes in caregiver self-efficacy in pain management, adherence to prescribed pain treatments, caregiver burden, stress, depression, and communication with healthcare providers. The study will also examine potential mediators (caregiver knowledge, communication) and moderators (caregiver characteristics, dementia severity, caregiving relationship) of intervention effects.
Additionally, the study will explore whether improvements in caregiver outcomes are associated with better outcomes for care recipients, such as reduced pain intensity and fewer urgent care visits related to pain.
Data collected will inform refinement of the PACE-app and guide the design of a future large-scale efficacy trial.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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).
Usual Pain Management Care
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.
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.
Web-based pain management support tool
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.
Interventions
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Web-based pain management support tool
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
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Be responsible for managing the care recipient's pain and pain treatments (including interpreting verbal or non-verbal pain communication).
* Be age 18 - 100.
* Be able to read and speak English.
* Have regular access to an electronic device (tablet, laptop, or computer) with internet connectivity (for using the app and participating in data collection).
* Be accessible by phone or email to schedule meetings.
* Be willing to commit to the full study duration and protocol.
Exclusion Criteria
18 Years
100 Years
ALL
Yes
Sponsors
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Alzheimer's Association
OTHER
University of Iowa
OTHER
Responsible Party
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Nai-Ching Chi
Associate Professor
Principal Investigators
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Nai-Ching Chi, PhD, MS, MSN, BSN
Role: PRINCIPAL_INVESTIGATOR
University of Iowa
Locations
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College of Nursing
Iowa City, Iowa, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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AARGD-22-929062
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
202409203
Identifier Type: -
Identifier Source: org_study_id
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