E-Tailored Pain Management Support for Dementia Family Caregivers: Feasibility of the PACE-app
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorUniversity of Iowa
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Currently participating in another research study that could interfere with this intervention.
Trial design
Design model
Parallel
Treatments tested in this trial
Web-based pain management support tool
Other interventionThe 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
BehavioralCaregivers 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Usual Care GroupActive comparator 1 intervention
Group B: App Use GroupExperimental treatment 1 intervention
Trial outcomes
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
Time frame
Change from baseline to 1 month and 2 monthsSecondary outcomes
1
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 moths2
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 months3
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 months4
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 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Iowa
Lead sponsor
Alzheimer's Association
Collaborator
Source ClinicalTrials.gov