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History of Changes for Study: NCT03853291
Developing a Pain Identification and Communication Toolkit (PICT)
Latest version (submitted June 6, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 February 22, 2019 None (earliest Version on record)
2 July 11, 2019 Contacts/Locations, Study Status and Study Description
3 August 12, 2019 Contacts/Locations, Outcome Measures, Study Status and Study Design
4 March 12, 2020 Recruitment Status, Study Status and Contacts/Locations
5 March 19, 2021 Study Status, Contacts/Locations and Eligibility
6 May 17, 2021 Study Status
7 June 23, 2021 Recruitment Status, Study Status and Contacts/Locations
8 August 26, 2021 Recruitment Status, Study Status, Study Design
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Results Submission Events
9 June 6, 2022 Recruitment Status, Study Status, Outcome Measures, Arms and Interventions, Document Section, Results, Eligibility, Study Design and Sponsor/Collaborators
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Study NCT03853291
Submitted Date:  February 22, 2019 (v1)

Open or close this module Study Identification
Unique Protocol ID: 1811019718
Brief Title: Developing a Pain Identification and Communication Toolkit (PICT)
Official Title: Developing a Pain Identification and Communication Toolkit for Family Caregivers of Persons With Dementia
Secondary IDs: 3P30AG022845-15S1 [U.S. NIH Grant/Contract]
Open or close this module Study Status
Record Verification: February 2019
Overall Status: Not yet recruiting
Study Start: August 2019
Primary Completion: February 2021 [Anticipated]
Study Completion: February 2021 [Anticipated]
First Submitted: February 22, 2019
First Submitted that
Met QC Criteria:
February 22, 2019
First Posted: February 25, 2019 [Actual]
Last Update Submitted that
Met QC Criteria:
February 22, 2019
Last Update Posted: February 25, 2019 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Weill Medical College of Cornell University
Responsible Party: Sponsor
Collaborators: National Institute on Aging (NIA)
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring:
Open or close this module Study Description
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 PWD 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 PWD, b) coaching in effective communication about PWD'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 PWD 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.
Detailed Description:
Open or close this module Conditions
Conditions: Dementia
Chronic Pain
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Screening
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 80 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: PICT Workbook
PICT Workbook components will include: 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.
Behavioral: PICT Workbook
The length of PICT and the delivery model will be informed by observational research that has been approved as part of this protocol (the first participant in the observational phase of this work will be enrolled on March 7, 2019). Lacking knowledge from the information gleaned from the observational and field-testing phases of this study we cannot specify with 100% certainty what the intervention will look like. However, it is likely that PICT will consist of 4-5 weekly 30-minute sessions); the expected delivery model will likely include a combination of online (video observation) and telephone coaching.
Active Comparator: Information Pamphlet
Informational pamphlet about pain in dementia and a link to the Alzheimer's Association website.
Behavioral: Information Pamphlet
Pamphlet with information about pain and dementia and links to Alzheimer's Association
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Feasibility, as measured by the number of sessions completed by participants in the intervention condition
[ Time Frame: Post-intervention, 3 months ]

Feasibility, as measured by the number of sessions completed by participants in the intervention condition
2. Feasibility, as measured by the number of participants recruited
[ Time Frame: Post-intervention, 3 months ]

Feasibility, as measured by the number of participants recruited
3. Acceptability, as measured by the number of participants who report that they are "satisfied" or "very satisfied" with the intervention
[ Time Frame: Post-intervention, 3 months ]

Acceptability, as measured by the number of caregivers who report that they are "satisfied" or "very satisfied" with the intervention
Secondary Outcome Measures:
1. Caregiver initiated pain-related communication, as measured by the number of caregivers who makes contact with health care providers to discuss pain-related concerns
[ Time Frame: At 3 months ]

Caregiver initiated pain-related communication, as measured by the number of caregivers who makes contact with health care providers to discuss pain-related concerns
Open or close this module Eligibility
Minimum Age: 21 Years
Maximum Age: 89 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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
Open or close this module Contacts/Locations
Central Contact Person: Emily Petti, BA
Telephone: 212-746-7317
Email: emp2007@med.cornell.edu
Central Contact Backup: Patricia Kim, MA
Telephone: 212-746-1758
Email: pak2020@med.cornell.edu
Study Officials: Cary Reid, MD/PhD
Principal Investigator
Weill Medical College of Cornell University
Catherine Riffin, PhD
Principal Investigator
Weill Medical College of Cornell University
Locations: United States, New York
Weill Cornell Medicine
New York, New York, United States, 10065
Contact:Contact: Emily Petti, BA 212-746-7317 emp2007@med.cornell.edu
Contact:Principal Investigator: Cary Reid
Contact:Principal Investigator: Catherine Riffin
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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