← Back to Search

Pain Communication Toolkit for Caregivers of Alzheimer's Patients (PICT Trial)

N/A

Recruiting

Led By Catherine A Riffin, PhD

Research Sponsored by Weill Medical College of Cornell University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

PATIENT PARTICIPANTS: Record of dementia or cognitive impairment

PATIENT PARTICIPANTS: Not in active cancer treatment

Must not have

CAREGIVER PARTICIPANTS: Visits care recipient less than weekly

CAREGIVER PARTICIPANTS: Age 20 or younger

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 1 month, 3 month, 6 month

Summary

This trial will evaluate a toolkit to help caregivers of Alzheimer's and dementia patients better recognize and communicate about pain. Recruiting participants from PACE. Hypothesize it will help caregivers.

Who is the study for?

This trial is for caregivers over 21 years old who speak English, are cognitively intact, and provide weekly care to someone with dementia or cognitive impairment and chronic pain enrolled in a PACE program. The person with dementia must not be in hospice or have a terminal illness with less than 6 months life expectancy.

What is being tested?

The study tests the Pain Identification and Communication Toolkit (PICT), designed to help caregivers of people with Alzheimer's disease recognize and communicate about their care recipient's pain through training and coaching.

What are the potential side effects?

Since this intervention involves educational tools rather than medications, traditional side effects are not expected. However, participants may experience emotional or psychological stress related to caregiving challenges.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with dementia or cognitive impairment.

Select...

I am not currently undergoing treatment for cancer.

Select...

I am a caregiver and I speak English.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I visit the person I care for less than once a week.

Select...

I am a caregiver and I am 20 years old or younger.

Select...

I am currently receiving treatment for cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 1 month, 3 month, 6 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 1 month, 3 month, 6 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1 month, 3 month, 6 month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in caregiver's ability to recognize pain

Change in caregiver's ability to recognize pain behaviors

Change in caregiver-reported pain communication

+2 more

Secondary study objectives

Change in caregiver burden

Change in caregiver distress level

Change in caregiver self-confidence in recognizing pain

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Pain Identification and Communication ToolkitExperimental Treatment1 Intervention

The Pain Identification and Communication Toolkit (PICT) components include: a) training using an observational assessment tool to detect pain in persons with Alzheimer's disease and related dementias (ADRD), b) coaching and feedback by a trained interventionist in effective strategies for communicating with providers about pain, c) future planning for what steps to take when a pain symptom is detected, and d) updating the caregiver's skill set through routine practice and homework exercises. A trained interventionist will deliver the PICT intervention following a manualized protocol to the caregiver participants. Patient participants will not receive any intervention.

Group II: Attention ControlPlacebo Group1 Intervention

The Attention Control (AC) condition, also known as the Health Promotion Program (HPP), focuses on caregiver health promotion topics, such as nutrition, exercise, and sleep. A trained interventionist will provide education on these topics using scripted material, use active listening and open questioning techniques, and provide the HPP participants with worksheets (e.g., meal plans) to complete between sessions to mirror the homework activities in the PICT condition for the caregiver participants. Patient participants will not receive any intervention.

0 / 6Eligibility criteria met