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

University of Iowa

Status: Enrolling

Conditions: Pain Management; Care Giving Burden; Chronic Pain; Dementia; Palliative Care

Treatments: Behavioral: Usual Pain Management Care; Other: Web-based pain management support tool

Study type: Interventional

Funder types: Other

Identifiers

NCT07032350

202409203

AARGD-22-929062 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

This randomized controlled trial will assess the feasibility, usability, and preliminary efficacy of the Pain Control Enhancement App (PACE-app), a web-based intervention designed to support family caregivers of persons with dementia in managing pain. The trial will also explore mechanisms through which the PACE-app may affect caregiver and care recipient outcomes.

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Usual Care Group

Active Comparator group

Description:

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).

Treatment:

Behavioral: Usual Pain Management Care

App Use Group

Experimental group

Description:

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.

Treatment:

Other: Web-based pain management support tool