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Recruiting NCT06168604

Evaluating the Efficacy of the Pain Identification and Communication Toolkit

No phase Interventional Caregiver Burden Cognitive Impairment Dementia Alzheimer Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pain Identification and Communication Toolkit, Health Promotion Program.
Who it may be relevant to
Registry conditions: Caregiver Burden, Cognitive Impairment, Dementia, Alzheimer Disease. Basic parameters: from 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

The Pain Identification and Communication Toolkit: A Training Program to Support Family Caregivers of Persons With ADRD

Overview

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

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.

Interventions

  • Behavioral 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
  • 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.

Primary outcome measures

  • 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]
Secondary outcome measures (7)
  • Change in patient's behavioral disturbance [Time frame: Baseline, 1 month, 3 month, 6 month]
  • Change in patient's pain treatments or regimens [Time frame: Baseline, 1 month, 3 month, 6 month]
  • Change in caregiver burden [Time frame: Baseline, 1 month, 3 month, 6 month]
  • Change in caregiver distress level [Time frame: Baseline, 1 month, 3 month, 6 month]
  • Change in caregiver self-efficacy in pain recognition [Time frame: Baseline, 1 month, 3 month, 6 month]
  • Change in caregiver self-confidence in recognizing pain [Time frame: Baseline, 1 month, 3 month, 6 month]
  • Change in caregiver self-efficacy in pain-related communication [Time frame: Baseline, 1 month, 3 month, 6 month]

Eligibility criteria

CAREGIVER PARTICIPANTS

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Inclusion criteria

  • Residing in community settings
  • Record of dementia or cognitive impairment
  • Diagnosis of pain
  • Responsive to environment
  • No terminal illness with life expectancy <6 months
  • Not in active cancer treatment

Exclusion criteria

  • Lives in a residential facility (such as a nursing home or assisted living)
  • Enrolled in hospice
  • No dementia or cognitive impairment
  • Unresponsive to environment
  • Has terminal illness with life expectancy <6 months
  • Are in active cancer treatment

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Health services research

Study locations

United States · 1 center
  • Weill Cornell Medicine — New York

Publications

  • Turner SG, Brody L, Mei L, Figueroa-Nieves A, Smiley A, Reid MC, Herr K, Sacerio L, Moxley J, Pillemer K, Riffin C. The pain identification and communication toolkit: a training program to support family caregivers of persons with ADRD. BMC Geriatr. 2025 Dec 4;26(1):31. doi: 10.1186/s12877-025-06717-8. PMID 41345575

Identifiers

NCT: NCT06168604 · 22-08025205 · R01AG079932

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗