Clinical trial NCT03853291: Developing a Pain Identification and Communication Toolkit
Official title: Developing a Pain Identification and Communication Toolkit for Family Caregivers of Persons With Dementia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Dementia
Chronic Pain
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: Cornell University
name: Rutgers University
name: University of Iowa
First posted: 2019-02-25
Enrollment: 85
Sex: ALL
Minimum age (years): 21
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.


Eligibility criteria: For all phases:

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:

Healthcare professionals:

* Currently providing clinical services to persons with dementia and/or chronic pain
* Has provided these clinical services for at least 1 year

Primary outcomes:
measure: Feasibility, as Measured by the Number of Participants in the Intervention Condition Who Completed All Sessions
timeFrame: Post-intervention, 3 months
measure: Feasibility, as Measured by the Number of Participants Recruited
timeFrame: Baseline
measure: 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
timeFrame: Post-intervention, 3 months
Secondary outcomes:
measure: 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
timeFrame: Baseline, Post-intervention-3 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Cary Reid, MD/PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Weill Medical College of Cornell University
name: Catherine Riffin, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cornell University
name: Karl Pillemer, PhD
role: PRINCIPAL_INVESTIGATOR
References: