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Evaluating the Efficacy of the Pain Identification and Communication Toolkit

NCT ID: NCT06168604

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

440 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-14

Study Completion Date

2028-02-01

Brief Summary

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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.

Detailed Description

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Up to 60% of older persons with Alzheimer's disease and related dementias (ADRD) suffer from bothersome pain and nearly half experience pain-related activity limitations. Despite best-practice guidelines calling for routine pain assessment of persons with ADRD, pain is severely under-detected and poorly managed in this population. A major barrier to the identification and treatment of pain in persons with ADRD is impaired communication. Informal (family) caregivers are well situated to detect pain and facilitate management in persons with ADRD, given their extensive involvement in care activities. However, caregivers receive virtually no guidance or training in these areas. The Pain Identification and Communication Toolkit (PICT) is a multicomponent intervention for ADRD caregivers that provides training in observational pain assessment and coaching in effective pain communication techniques. PICT consists of 4 weekly telephone sessions (30-60 minutes each) delivered by a trained interventionist. This project aims to (1) determine the efficacy of PICT compared with an Attention Control (AC) condition, (2) identify the patient and caregiver factors that may moderate the effects of PICT on study outcomes, and (3) evaluate the mechanisms (theoretically-derived variables) by which PICT affects study outcomes. Participants will be recruited from programs of all-inclusive care for the elderly (PACE) programs and partnering health care clinics. They will complete assessments at 0 (baseline), 1, 3, and 6 months.

Conditions

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Caregiver Burden Cognitive Impairment Dementia Alzheimer Disease Pain, Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

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Pain Identification and Communication Toolkit

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 Type EXPERIMENTAL

Pain Identification and Communication Toolkit

Intervention Type 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

Attention Control

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.

Group Type SHAM_COMPARATOR

Health Promotion Program

Intervention Type 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.

Interventions

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Pain Identification and Communication Toolkit

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

Intervention Type BEHAVIORAL

Health Promotion Program

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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


1. Residing in community settings
2. Record of dementia or cognitive impairment
3. Diagnosis of pain
4. Responsive to environment
5. No terminal illness with life expectancy \<6 months
6. Not in active cancer treatment

Exclusion Criteria

1. Paid caregiver
2. Age 20 or younger
3. Non-English speaking
4. Cognitively impaired
5. Does not provide care to a person with dementia or cognitive impairment who also has a pain diagnosis
6. Currently enrolled in hospice
7. The patient to whom the caregiver provides assistance is enrolled in hospice
8. Visits care recipient less than weekly
9. Not accessible by telephone.

PATIENT PARTICIPANTS


1. Lives in a residential facility (such as a nursing home or assisted living)
2. Enrolled in hospice
3. No dementia or cognitive impairment
4. Unresponsive to environment
5. Has terminal illness with life expectancy \<6 months
6. Are in active cancer treatment
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Catherine A Riffin, PhD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

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Weill Cornell Medicine

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Lisa Sacerio

Role: CONTACT

[email protected]
646-962-6941

Facility Contacts

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Lisa Sacerio

Role: primary

[email protected]
646-962-6941

Other Identifiers

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R01AG079932

Identifier Type: NIH

Identifier Source: secondary_id

View Link

22-08025205

Identifier Type: -

Identifier Source: org_study_id