Developing a Pain Identification and Communication Toolkit

Chronic Pain Clinical Trial

— PICT  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03853291
• Other study ID #: 1811019718
• Secondary ID: 3P30AG022845-15S
• Status: Terminated
• Phase: N/A
• Start date: March 8, 2019
• Est. completion date: August 11, 2021

Study information

• Verified date: June 2022
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 85
• Est. completion date: August 11, 2021
• Est. primary completion date: August 11, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Dementia

Intervention

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

Locations

Country	Name	City	State
United States	Weill Cornell Medicine	New York	New York

Sponsors (5)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	Cornell University, National Institute on Aging (NIA), Rutgers University, University of Iowa

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility, as Measured by the Number of Participants in the Intervention Condition Who Completed All Sessions		Post-intervention, 3 months
Primary	Feasibility, as Measured by the Number of Participants Recruited		Baseline
Primary	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		Post-intervention, 3 months
Secondary	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