Идёт набор NCT07032350

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

Без фазы С лечением Care Giving Burden Dementia Chronic Pain Pain Management

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Web-based pain management support tool, Usual Pain Management Care.
Кому может быть актуально: Состояния в реестре: Care Giving Burden, Dementia, Chronic Pain, Pain Management. Базовые параметры: 18 лет — 100 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

E-Tailored Pain Management Support for Dementia Family Caregivers

Обзор

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.

Подробное описание

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.

Вмешательства

Другое 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 i
Поведенческое Usual Pain Management 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.

Первичные конечные точки

Caregiver Self-Efficacy in Pain Management [Срок оценки: Change from baseline to 1 month and 2 months]

Вторичные конечные точки (6)

Caregiver adherence to Pain Treatments [Срок оценки: Baseline, 1 month, 2 moths]
Caregiver Burden [Срок оценки: Baseline, 1 month, 2 months]
Caregiver Stress [Срок оценки: Baseline, 1 month, 2 months]
Caregiver Depression [Срок оценки: Baseline, 1 month, 2 months]
Caregiver Knowledge in Pain Management [Срок оценки: Baseline, 1 month, 2 months]
Caregiver Communication with Providers [Срок оценки: Baseline, 1 month, 2 months]

Критерии участия

Критерии включения

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.