An interventional study of Web-based pain management support tool and Usual Pain Management Care in Care Giving Burden, Dementia and Chronic Pain, sponsored by University of Iowa. Recruiting at 1 site in United States. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-29.
Sponsored by University of Iowa · Not applicable, Interventional, and Supportive care
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.
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.
422 studies on the registry are indexed under Caregiver Burden; 151 are open to participants now.
This study's planned enrollment of 60 is below the median of 73 across 330 interventional studies indexed under Caregiver Burden.
Browse Caregiver Burden studies →University of Iowa is the lead sponsor of 276 studies on the registry; 35 are open to participants now.
Of its 44 completed or terminated interventional studies of FDA-regulated products, 39 (89%) have results posted.
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Exclusion Criteria:
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
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
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
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
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
Time frame: Change from baseline to 1 month and 2 months
Caregiver adherence to Pain Treatments
Measured using the 12-itemthe modified Adherence to Refills and Medications Scale (ARMS). Each item uses a 4-point Likert scale (1, never to 4, all the time). Higher scores (ranging 12 to 48) indicate poorer adherence. Cut-off scores define different adherence levels (e.g., \<16=adherent, ≥20=non-adherent).
Time frame: Baseline, 1 month, 2 moths
Caregiver Burden
Measured using the 12-item Zarit Burden Interview (ZBI-12). Responses use a 5-point scale (0, never to 4, nearly always). Higher scores (ranging 0 to 48) reflect greater burden.
Time frame: Baseline, 1 month, 2 months
Caregiver Stress
Measured using the 14-item Perceived Stress Scale (PSS-14). PSS-14 asks family caregivers about their feelings and thoughts over the past month, using a 5-point Likert scale (0 = never to 4 = very often). Higher scores (ranging from 0 to 56) indicate greater perceived stress.
Time frame: Baseline, 1 month, 2 months
Caregiver Depression
Measured using the 20-item Center for Epidemiologic Studies Depression Scale (CES-D). Answers are given on a 4-point scale (0, rarely to 3, most of the time). Total scores range from 0 to 60, with higher scores indicating more severe depressive symptoms.
Time frame: Baseline, 1 month, 2 months
Caregiver Knowledge in Pain Management
Modified 17-item scale originally developed for nurses, adapted for caregivers. Each item is rated on a five-point Likert scale (1 = completely disagree to 5 = completely agree). Higher total scores (ranging from 17 to 85) indicate less knowledge in pain management.
Time frame: Baseline, 1 month, 2 months
Caregiver Communication with Providers
Measured using modified Perceived Involvement in Care Scale (M-PICS). It contains 21 statements scored on a 5-point Likert scale (1, strongly disagree to 5, strongly agree). Total possible scores range from 20 (least perceived involvement) to 100 (most perceived involvement). Higher scores indicate greater perceived involvement in care.
Time frame: Baseline, 1 month, 2 months
Plan to share: No — To protect participant privacy, individual participant data (IPD) collected in this study will not be shared with other researchers. Only aggregated study results will be published.
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