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Clinical Trials/NCT03853291
NCT03853291
Terminated
Not Applicable

Developing a Pain Identification and Communication Toolkit for Family Caregivers of Persons With Dementia

Weill Medical College of Cornell University1 site in 1 country85 target enrollmentMarch 8, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dementia
Sponsor
Weill Medical College of Cornell University
Enrollment
85
Locations
1
Primary Endpoint
Feasibility, as Measured by the Number of Participants in the Intervention Condition Who Completed All Sessions
Status
Terminated
Last Updated
3 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
March 8, 2019
End Date
August 11, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Family caregiver
  • Age 21 or older
  • English speaking
  • Cognitively intact
  • Provides at least 8 hours of care per week to a person with dementia and pain
  • Has provided care for at least 6 months

Exclusion Criteria

  • Paid caregiver
  • Age 20 or younger
  • Non-English speaking
  • Cognitively impaired
  • Does not provide at least 8 hours of care per week to a person with dementia who also has a pain diagnosis
  • Has not provided care for at least 6 months
  • Currently enrolled in hospice
  • The patient to whom the caregiver provides assistance is in enrolled in hospice
  • Care recipient does not have dementia diagnosis or pain diagnosis
  • For field test and interview phases:

Outcomes

Primary Outcomes

Feasibility, as Measured by the Number of Participants in the Intervention Condition Who Completed All Sessions

Time Frame: Post-intervention, 3 months

Feasibility, as Measured by the Number of Participants Recruited

Time Frame: Baseline

Acceptability, as Measured by the Number of Participants Who Report That the Intervention Was "Very Effective" or "Moderately Effective" in Helping Them Feel More Confident in Their Ability to Communicate Pain to Healthcare Providers

Time Frame: Post-intervention, 3 months

Secondary Outcomes

  • Caregiver Initiated Pain-related Communication, as Measured by the Number of Caregivers Who Report Making Contact With Any of the Care Recipients' Health Care Providers to Discuss Pain-related Concerns(Baseline, Post-intervention-3 months)

Study Sites (1)

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