- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03853291
Developing a Pain Identification and Communication Toolkit (PICT)
June 6, 2022 updated by: Weill Medical College of Cornell University
Developing a Pain Identification and Communication Toolkit for Family Caregivers of Persons With Dementia
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
85
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10065
- Weill Cornell Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PICT Workbook
PICT Workbook components 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 through routine practice.
|
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.
|
Active Comparator: Information Pamphlet
Informational pamphlet about pain in dementia and a link to the Alzheimer's Association website.
|
Pamphlet with information about pain and dementia and links to Alzheimer's Association
|
No Intervention: Family Caregivers - Interview Phase
Interviews will be conducted with family caregivers and health care providers in-person in private offices at WCMC/NYP or over the telephone.
The primary objectives of the qualitative interviews are to: a) adapt the PAINAD for use with caregivers by asking them to comment on its format and content; and b) generate an initial question pool for the Question Prompt List.
After reviewing the PICT workbook, caregivers will complete a brief qualitative questionnaire about the content, format, and perceived utility of PICT, as well as ways to enhance its cultural relevance.
They will also complete a semi-structured interview to clarify their perspectives.
Health care providers will answer a similar set of questions.
Results from this first field-test will inform the next version of PICT and address key issues, such as the feasibility of using research nurses to administer the intervention, anticipation of participant burden for caregivers, and adequacy of PICT format and instructions.
|
|
No Intervention: Healthcare Providers - Interview Phase
Interviews will be conducted with family caregivers and health care providers in-person in private offices at WCMC/NYP or over the telephone.
The primary objectives of the qualitative interviews are to: a) adapt the PAINAD for use with caregivers by asking them to comment on its format and content; and b) generate an initial question pool for the Question Prompt List.
After reviewing the PICT workbook, caregivers will complete a brief qualitative questionnaire about the content, format, and perceived utility of PICT, as well as ways to enhance its cultural relevance.
They will also complete a semi-structured interview to clarify their perspectives.
Health care providers will answer a similar set of questions.
Results from this first field-test will inform the next version of PICT and address key issues, such as the feasibility of using research nurses to administer the intervention, anticipation of participant burden for caregivers, and adequacy of PICT format and instructions.
|
|
No Intervention: Family Caregivers - Field Test Phase
Once initial versions of the PICT manual and workbook are developed, they will be iteratively field-tested and vetted by family caregivers and health care providers.
After reviewing the PICT workbook, caregivers will complete a brief qualitative questionnaire about the content, format, and perceived utility of PICT, as well as ways to enhance its cultural relevance.
They will also complete a brief (15-20 minute) semi-structured interview to clarify their perspectives.
Health care providers will answer a similar set of questions.
Results from this first field-test will inform the modified version of PICT and will address key issues, such as the feasibility of using research nurses (and other practice staff) to administer the intervention, anticipation of participant burden for caregivers, and adequacy of PICT format and instructions.
|
|
No Intervention: Healthcare Providers - Field Test Phase
Once initial versions of the PICT manual and workbook are developed, they will be iteratively field-tested and vetted by family caregivers and health care providers.
After reviewing the PICT workbook, caregivers will complete a brief qualitative questionnaire about the content, format, and perceived utility of PICT, as well as ways to enhance its cultural relevance.
They will also complete a brief (15-20 minute) semi-structured interview to clarify their perspectives.
Health care providers will answer a similar set of questions.
Results from this first field-test will inform the modified version of PICT and will address key issues, such as the feasibility of using research nurses (and other practice staff) to administer the intervention, anticipation of participant burden for caregivers, and adequacy of PICT format and instructions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Feasibility, as Measured by the Number of Participants in the Intervention Condition Who Completed All Sessions
Time Frame: Post-intervention, 3 months
|
Post-intervention, 3 months
|
Feasibility, as Measured by the Number of Participants Recruited
Time Frame: Baseline
|
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
|
Post-intervention, 3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
Time Frame: Baseline, Post-intervention-3 months
|
Baseline, Post-intervention-3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Cary Reid, MD/PhD, Weill Medical College of Cornell University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 8, 2019
Primary Completion (Actual)
August 11, 2021
Study Completion (Actual)
August 11, 2021
Study Registration Dates
First Submitted
February 22, 2019
First Submitted That Met QC Criteria
February 22, 2019
First Posted (Actual)
February 25, 2019
Study Record Updates
Last Update Posted (Actual)
June 7, 2022
Last Update Submitted That Met QC Criteria
June 6, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1811019718
- 3P30AG022845-15S1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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