Recruiting

Pain Identification

Sponsor:

Weill Medical College of Cornell University

Code:

NCT06168604

Conditions

Caregiver Burden

Cognitive Impairment

Dementia

Alzheimer Disease

Pain, Chronic

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Pain Identification and Communication Toolkit

Health Promotion Program

Study Details

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

Caregiver Burden

Cognitive Impairment

Dementia

Alzheimer Disease

Pain, Chronic

Study ID

NCT06168604

Start date

Dec 14, 2023

Status verified date

Feb, 2026

Completion date

Oct 30, 2027

Anticipated

Primary completion date

Oct 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

CAREGIVER PARTICIPANTS

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

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

Inclusion Criteria:

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. 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

Study Design

Enrollment

440 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: 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.

sham comparator: 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.

Interventions

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

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.

Primary outcome measure

  • Change in caregiver-reported pain communication [ Time Frame: Baseline, 1 month, 3 month, 6 month ]
  • Change in pain management discussions with health care providers [ Time Frame: Baseline, 1 month, 3 month, 6 month ]
  • Change in concordance between patient and caregiver pain ratings [ Time Frame: Baseline, 1 month, 3 month, 6 month ]
  • Change in caregiver's ability to recognize pain [ Time Frame: Baseline, 1 month, 3 month, 6 month ]
  • Change in caregiver's ability to recognize pain behaviors [ Time Frame: Baseline, 1 month, 3 month, 6 month ]

Central Contacts and Locations

Central contacts

Lisa Sacerio

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

Locations

Weill Cornell Medicine

Recruiting

New York, New York, United States, 10065

Contacts

Lisa Sacerio

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

More Information

Sponsor

Weill Medical College of Cornell University

Last update posted

Feb 12, 2026

Last verified

Feb, 2026

Keywords

  • Family Caregivers
  • Informal Caregivers
  • Dementia
  • Pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Weill Medical College of Cornell University on 2026-02-12.