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

NCT07032350 | Recruiting

• 2 other identifiers: 202409203AARGD-22-929062
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (1)

• Caregiver Self-Efficacy in Pain Management

  Measured using the pain managment subscale of the Chronic Pain Self-Efficacy Scale (CPSS). This 7-item scale on a 10-100 scale assesses confidence in skills such as medication management, and non-pharmacological techniques. Higher scores indicate greater self-efficacy

  Change from baseline to 1 month and 2 months

Secondary Outcomes (6)

• Caregiver adherence to Pain Treatments

  Baseline, 1 month, 2 moths

• Caregiver Burden

  Baseline, 1 month, 2 months

• Caregiver Stress

  Baseline, 1 month, 2 months

• Caregiver Depression

  Baseline, 1 month, 2 months

• Caregiver Knowledge in Pain Management

  Baseline, 1 month, 2 months

Study Arms (2)

Usual Care Group

ACTIVE COMPARATOR

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).

Behavioral: Usual Pain Management Care

App Use Group

EXPERIMENTAL

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.

Other: Web-based pain management support tool

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.

Also known as: PACE-app

App Use Group

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.

Also known as: Usual Care

Usual Care Group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Iowa: lead
• Alzheimer's Association: collaborator

Study Sites (1)

College of Nursing

Iowa City, Iowa, 52246, United States

RECRUITING

MeSH Terms

Conditions

Caregiver Burden; Dementia; Chronic Pain; Agnosia; Alzheimer Disease; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Tauopathies; Neurodegenerative Diseases; Cognition Disorders

Study Officials

• Nai-Ching Chi, PhD, MS, MSN, BSN

  University of Iowa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nai-Ching Chi, PhD, MS, BSN

CONTACT

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

Gabriel M Vald, MS, BA

CONTACT

515-897-8517; gmvald@uiowa.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 19, 2025
• First Posted: June 24, 2025
• Study Start: May 22, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: June 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)