Care Giving BurdenPACE-appNCT07032350
E-Tailored Pain Management Support for Dementia Family Caregivers: Feasibility of the PACE-app
A study testing Web-based pain management support tool and Usual Pain Management Care in people with Care Giving Burden and Dementia, run by University of Iowa at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Care Giving Burden, Dementia, Chronic Pain
- What is being tested?
- Web-based pain management support tool and Usual Pain Management Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 22 May 2025to May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Currently participating in another research study that could interfere with this intervention.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
College of Nursing
Iowa City, Iowa, 52246
Nai-Ching Chi, PhD, MS, MSN, BSN, 319-335-7064, nai-ching-chi@uiowa.edu
Gabriel M Vald, MS, BA, 515-897-8517, gmvald@uiowa.edu
About this study
Official title: E-Tailored Pain Management Support for Dementia Family Caregivers
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?
Read more
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.
Read the detailed 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.
- Conditions
- Care Giving Burden, Dementia, Chronic Pain, Pain Management, Palliative Care
- Being tested
- Web-based pain management support tool, Usual Pain Management 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
- Medical subject headings
- Caregiver Burden, Dementia, Chronic Pain, Agnosia, Alzheimer Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-based pain management support toolOther
Also called PACE-app
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 CareBehavioural
Also called Usual 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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Other: Web-based pain management support tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Change from baseline to 1 month and 2 months
Secondary outcomes (6)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 1 month, 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start22 May 2025
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Care Giving BurdenStudies of the same condition, open and under way.
- More trials run by University of IowaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Collaborators
- Alzheimer's Association
- Responsible party
- Principal investigator, Nai-Ching Chi, University of Iowa
- Investigators
- Nai-Ching Chi, PhD, MS, MSN, BSN, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07032350
- Sponsor's protocol ID
- 202409203
- Other IDs
- AARGD-22-929062
- Acronym
- PACE-app
- Status last verified
- Jun 2025
- First submitted
- 19 Jun 2025
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- E-Tailored Pain Management Support for Dementia Family Caregivers
- ClinicalTrials.gov ID
- NCT07032350
- Acronym / sponsor ID
- PACE-app / 202409203
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Collaborators
- Alzheimer's Association
- Study start
- 22 May 2025 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 24 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care Group | Active comparator | Behavioral: Usual Pain Management CareCare 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). |
| App Use Group | Experimental | Other: Web-based pain management support toolCare 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (1 listed)
- Currently participating in another research study that could interfere with this intervention.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Web-based pain management support toolAlso: PACE-appThe 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. | Other | App Use Group |
| Usual Pain Management CareAlso: Usual CareCaregivers 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. | Behavioural | Usual Care Group |
Primary outcome
Caregiver Self-Efficacy in Pain Management
Time frame: Change from baseline to 1 month and 2 months
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
6 secondary outcomes
Caregiver adherence to Pain Treatments
Time frame: Baseline, 1 month, 2 moths
Caregiver Burden
Time frame: Baseline, 1 month, 2 months
Caregiver Stress
Time frame: Baseline, 1 month, 2 months
Caregiver Depression
Time frame: Baseline, 1 month, 2 months
Caregiver Knowledge in Pain Management
Time frame: Baseline, 1 month, 2 months
Caregiver Communication with Providers
Time frame: Baseline, 1 month, 2 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nai-Ching Chi, PhD, MS, MSN, BSN principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web-based pain management support tool and Usual Pain Management Care in people with Care Giving Burden and Dementia, run by University of Iowa at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nai-Ching Chi, PhD, MS, BSN (319-335-7064, nai-ching-chi@uiowa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caregiver Self-Efficacy in Pain Management (time frame: Change from baseline to 1 month and 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2025.