Evaluating the Efficacy of the Pain Identification and Communication Toolkit

Part of paid clinical trials in New York, New York.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT06168604
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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
  • 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.

Study Details

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.

Key Dates

Start date
Dec 14, 2023
Status verified
Feb 2026
Primary completion
Oct 30, 2027
Completion
Oct 30, 2027

Study Design

Enrollment
440 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

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.

Primary Outcome Measure

Change in caregiver-reported pain communication [ Time Frame: Baseline, 1 month, 3 month, 6 month ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Weill Cornell MedicineNew YorkNew York10065
Lisa Sacerio
[email protected]
646-962-6941

Find similar trials in New York, NY

By condition
Alzheimer's disease
By specialty
NeurologyDementia careBrain disordersGeriatrics
By research site
Weill Cornell Medicine· New York, NY

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