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Pain Identification and Communication Toolkit for Dementia (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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

PICT Trial 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.Check my eligibility

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.See study design

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.

PICT Trial Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with dementia or cognitive impairment.

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I am not currently undergoing treatment for cancer.

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I am a caregiver and I speak English.

PICT Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

Change in caregiver burden

Change in caregiver distress level

Change in caregiver self-confidence in recognizing pain

+4 more

PICT 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 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute on Aging (NIA)NIH

1,675 Previous Clinical Trials

28,020,445 Total Patients Enrolled

268 Trials studying Dementia

23,627,166 Patients Enrolled for Dementia

Weill Medical College of Cornell UniversityLead Sponsor

1,055 Previous Clinical Trials

1,315,855 Total Patients Enrolled

7 Trials studying Dementia

2,764 Patients Enrolled for Dementia

Catherine A Riffin, PhDPrincipal InvestigatorWeill Medical College of Cornell University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies in this clinical trial?

"According to clinicaltrials.gov, this medical trial is still looking for participants and was first advertised on December 1st 2023 with the latest update posted around December 12th of that same year."

Answered by AI

What is the maximum enrollment capacity for this research endeavor?

"Affirmative. Clinicaltrials.gov indicates that this clinical trial is currently enrolling patients and was first posted on December 1st 2023 with the most recent update occurring on December 12th of the same year. This medical research requires 440 participants from one site to be recruited."

Answered by AI

What results is the team hoping to see from this medical experiment?

"Primarily, this study aims to evaluate the efficacy of a particular intervention by measuring changes in caregivers' ability to recognise pain behaviours. Secondary objectives include gauging shifts in patients' behavioural disturbances (measured through an 11-item Memory and Behavior Problem Checklist assessed on a Likert scale from 0 - never occurs to 4 - occurs daily or more often), caregiver burden (7-item Zarit Burden Index ranging from 0 - 'never', up to 4 – nearly always) and distress levels (Memory & Behaviour Problem Checklist measured with responses between 0 not at all, up to 4 extremely). All these metrics will be"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Evaluating the Efficacy of the Pain Identification and Communication Toolkit

2023. "Evaluating the Efficacy of the Pain Identification and Communication Toolkit". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06168604.

All > Alzheimers Disease New York