Developing a Pain Identification and Communication Toolkit

NCT03853291 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2022-06-07

Study results available
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Summary

The proposed research will develop, refine, and pilot test the Pain Identification and Communication Toolkit (PICT), an intervention to help family caregivers of community-dwelling persons with dementia identify pain symptoms and communicate those symptoms to health care providers. Informed by self-efficacy theory, PICT will include: a) training in administering an observational assessment tool to identify pain in persons with dementia, b) coaching in effective communication about the person with dementia's pain symptoms, c) future planning for steps to take when pain is detected, and d) updating caregivers' skills through routine practice with the pain assessment tool. All components will be vetted and iteratively field-tested with a sample of racially and ethnically diverse caregivers of community-dwelling persons with dementia and health care providers. A two-group pilot randomized trial will examine the acceptability, feasibility, and preliminary impact of PICT on caregivers' initiation of pain-related communication with health care providers.

Conditions

Interventions

BEHAVIORAL

PICT Workbook

PICT Workbook: The PICT workbook is a 31-page manual, which includes: a) training using an observational assessment tool to detect pain in PWD, b) coaching and feedback by a research nurse in effective strategies for communicating with providers about PWD's pain, c) future planning for what steps to take when a pain symptom is detected, and d) updating the caregiver's skill set. Participants in the intervention condition also attended four weekly 30-minute sessions with an interventionist through a combination of online (video observation) and telephone coaching to go over the Workbook.

BEHAVIORAL

Information Pamphlet

Pamphlet with information about pain and dementia and links to Alzheimer's Association

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    collaborator NIH
  • Cornell University

    collaborator OTHER
  • Rutgers University

    collaborator OTHER
  • University of Iowa

    collaborator OTHER
  • Weill Medical College of Cornell University

    lead OTHER

Principal Investigators

  • Cary Reid, MD/PhD · Weill Medical College of Cornell University

  • Catherine Riffin, PhD · Weill Medical College of Cornell University

  • Karl Pillemer, PhD · Cornell University

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-08
Primary Completion
2021-08-11
Completion
2021-08-11

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03853291 on ClinicalTrials.gov