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NCT06168604 | RECRUITING | Caregiver Burden


Evaluating the Efficacy of the Pain Identification and Communication Toolkit
Sponsor:

Weill Medical College of Cornell University

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.

Condition or disease

Caregiver Burden

Cognitive Impairment

Dementia

Alzheimer Disease

Pain, Chronic

Intervention/treatment

Pain Identification and Communication Toolkit

Health Promotion Program

Phase

NA

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 440 participants
Masking : SINGLE
Masking Description : 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.
Primary Purpose : HEALTH_SERVICES_RESEARCH
Official Title : The Pain Identification and Communication Toolkit: A Training Program to Support Family Caregivers of Persons With ADRD
Actual Study Start Date : 2023-12-14
Estimated Primary Completion Date : 2027-10-30
Estimated Study Completion Date : 2027-10-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 21 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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

  • Evaluating the Efficacy of the Pain Identification and Communication Toolkit

    Location Details

    NCT06168604


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    Locations


    RECRUITING

    United States, New York

    Weill Cornell Medicine

    New York, New York, United States, 10065

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