Recruiting

PACE-app

Sponsor:

University of Iowa

Code:

NCT07032350

Conditions

Care Giving Burden

Dementia

Chronic Pain

Pain Management

Palliative Care

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Web-based pain management support tool

Usual Pain Management Care

Study Details

Brief summary:

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.

Conditions

Care Giving Burden

Dementia

Chronic Pain

Pain Management

Palliative Care

Study ID

NCT07032350

Start date

May 22, 2025

Status verified date

Jun, 2025

Completion date

May, 2026

Anticipated

Primary completion date

May, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Be a primary caregiver - (a family member, relative, or friend) of a person with dementia (or cognitive impairment) and chronic pain (lasting >3 months)'
  • 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:

  • Currently participating in another research study that could interfere with this intervention.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

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.

Interventions

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Nai-Ching Chi, PhD, MS, BSN

319-335-7064nai-ching-chi@uiowa.edu

Gabriel M Vald, MS, BA

515-897-8517gmvald@uiowa.edu

Locations

College of Nursing

Recruiting

Iowa City, Iowa, United States, 52246

Contacts

Nai-Ching Chi, PhD, MS, MSN, BSN

319-335-7064nai-ching-chi@uiowa.edu

Gabriel M Vald, MS, BA

515-897-8517gmvald@uiowa.edu

Principal Investigator:

Nai-Ching Chi, PhD, MS, MSN, BSN

More Information

Sponsor

University of Iowa

Last update posted

Jun 29, 2025

Last verified

Jun, 2025

Keywords

  • Dementia
  • Alzheimer Disease
  • Chronic Pain
  • Pain Management
  • Caregivers
  • Family Caregivers
  • Digital Health Intervention
  • eHealth
  • Web-based Intervention
  • Palliative Care
  • Home Care
  • Self-efficacy
  • Caregiver Stress
  • Caregiver Depression
  • Communication with Providers
  • Health Literacy
  • Rural Caregivers
  • Geriatrics
  • Aging
  • Cognitive Impairment
  • Pain Diary

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Iowa on 2025-06-29.