Evaluating the Efficacy of the Pain Identification and Communication Toolkit

NCT06168604 | Recruiting DMC

• 2 other identifiers: 22-08025205R01AG079932
• Study Type: interventional
• Target: 440
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the Pain Identification and Communication Toolkit (PICT), a multicomponent intervention for caregivers of people with Alzheimer's disease and related dementias (ADRD). PICT provides training in observational pain assessment and coaching in effective pain communication techniques. It will recruit participants from programs of all-inclusive care for the elderly (PACE) and partnering health care clinics. The investigators hypothesize that PICT will help caregivers to recognize and communicate about pain in their care recipients.

Conditions

Alzheimer Disease; Caregiver Burden; Cognitive Impairment; Dementia; Pain, Chronic

Keywords

Family Caregivers; Informal Caregivers; Dementia; Pain

Outcome Measures

Primary Outcomes (5)

• Change in caregiver-reported pain communication

  Change in caregiver-reported pain-related communication as measured by ten questions from the Perceived Involvement in Care Scale (PICS). The range of possible scores is 10-50, where higher scores indicate greater caregiver involvement in patient consultation.

  Baseline, 1 month, 3 month, 6 month

• Change in pain management discussions with health care providers

  Change in pain management discussions as measured by the combined number of phone calls and appointments made to discuss pain management recorded in the patient's medical chart.

  Baseline, 1 month, 3 month, 6 month

• Change in concordance between patient and caregiver pain ratings

  Change in concordance in patient and caregiver pain ratings as measured by the absolute difference between caregiver and patient pain ratings of the patient's pain on the Iowa Pain Thermometer (IPT). The IPT is scored on a scale of 0-10 where 0 means "no pain" and 10 means "the most intense pain imaginable."

  Baseline, 1 month, 3 month, 6 month

• Change in caregiver's ability to recognize pain

  Change in caregiver's ability to recognize pain as measured by the absolute difference between the caregiver-reported PAINAD score and correct PAINAD score (i.e. absolute value of the deviance between the scores). The PAINAD is scored on a scale from 0-10 where 0 means "no pain" and 10 means "severe pain." Participants will be shown multiple videos on which to score the PAINAD.

  Baseline, 1 month, 3 month, 6 month

• Change in caregiver's ability to recognize pain behaviors

  Change in caregiver's ability to recognize pain behaviors as measured by the absolute difference between the number of caregiver-reported behaviors within each of the 5 PAINAD behaviors (i.e., Breathing, Negative Vocalization, Facial Expression, Body Language, Consolability) and correct number of behaviors. Participants will be shown multiple videos on which to score the PAINAD.

  Baseline, 1 month, 3 month, 6 month

Secondary Outcomes (7)

• Change in patient's behavioral disturbance

  Baseline, 1 month, 3 month, 6 month

• Change in patient's pain treatments or regimens

  Baseline, 1 month, 3 month, 6 month

• Change in caregiver burden

  Baseline, 1 month, 3 month, 6 month

• Change in caregiver distress level

  Baseline, 1 month, 3 month, 6 month

• Change in caregiver self-efficacy in pain recognition

  Baseline, 1 month, 3 month, 6 month

Study Arms (2)

Pain Identification and Communication Toolkit

EXPERIMENTAL

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.

Behavioral: Pain Identification and Communication Toolkit

Attention Control

SHAM COMPARATOR

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.

Behavioral: Health Promotion Program

Interventions

Health Promotion Program BEHAVIORAL

The attention control (AC) condition is referred to as the Health Promotion Program (HPP). The HPP will consist of 4 weekly telephone sessions (30-60 minutes each) but focus on caregiver health promotion topics, such as nutrition, exercise, and sleep.

Attention Control

Pain Identification and Communication Toolkit BEHAVIORAL

The Pain Identification and Communication Toolkit (PICT) is a multicomponent (6 module) intervention for family caregivers of persons with Alzheimer's disease and related dementias (ADRD). PICT consists of 4 weekly telephone sessions (30-60 minutes each) delivered by a trained interventionist

Pain Identification and Communication Toolkit

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 21 or older
• Any gender
• English speaking
• Cognitively intact (BOMC ≤10)
• Provides care to a community-dwelling adult with dementia or cognitive impairment who also has a pain diagnosis
• Care recipient is not enrolled in hospice
• Visits the care recipient at least weekly
• Accessible by telephone

You may not qualify if:

• Paid caregiver
• Age 20 or younger
• Non-English speaking
• Cognitively impaired
• Does not provide care to a person with dementia or cognitive impairment who also has a pain diagnosis
• Currently enrolled in hospice
• The patient to whom the caregiver provides assistance is enrolled in hospice
• Visits care recipient less than weekly
• Not accessible by telephone.
• PATIENT PARTICIPANTS
• Residing in community settings
• Record of dementia or cognitive impairment
• Diagnosis of pain
• Responsive to environment
• No terminal illness with life expectancy \<6 months

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10065, United States

RECRUITING

MeSH Terms

Conditions

Caregiver Burden; Cognitive Dysfunction; Dementia; Alzheimer Disease; Chronic Pain; Pain

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Catherine A Riffin, PhD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa Sacerio

CONTACT

646-962-6941; lis4019@med.cornell.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single blind allocation. The outcomes assessors will be masked to group allocation. Other research personnel (investigator, project manager, interventionist) may become aware of group allocation. Participants will be asked not to disclose to outcomes assessors the group to which they are assigned.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2023
• First Posted: December 13, 2023
• Study Start: December 14, 2023
• Primary Completion (Estimated): October 30, 2027
• Study Completion (Estimated): October 30, 2027
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will become available at the earlier time point: either at time of an associated publication or the end of the grant's performance period. Data will be available for three years following the end of the grant period.
• Access Criteria: Data will be shared by the PI in accordance with NIH's data sharing policy. De-identified data will be shared upon request. External investigators will be able to access the data by contacting the PI who will share the curated data. Refined data, after de-identification, will be shared with investigators upon request. External investigators will be able to locate and access the data by contacting the PI who will share the curated dataset (as described above). Datasets from this study will be appropriate for deposit in archives at peer-reviewed journals that require data deposition. The PI agrees to share our data with researchers working under an institution with Federal Wide Assurance who agree to a data sharing agreement that stipulates protection of participant privacy and data confidentiality, that the data will be used for research only, and that data will not be transferred to other users.

Locations

US (1)