Ignite Creation Date:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2025-12-30 @ 9:44 PM
Study NCT ID:
NCT06168604
Status:
RECRUITING
Last Update Posted:
2025-12-17
First Post:
2023-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating the Efficacy of the Pain Identification and Communication Toolkit
Sponsor:
Weill Medical College of Cornell University
Organization:
Study Overview
Official Title:
The Pain Identification and Communication Toolkit: A Training Program to Support Family Caregivers of Persons With ADRD
Status:
RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PICT
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R01AG079932 | NIH | None | https://reporter.nih.gov/quic… | View |