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Developing a Pain Identification and Communication Toolkit (PICT)

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ClinicalTrials.gov Identifier: NCT03853291
Recruitment Status : Recruiting
First Posted : February 25, 2019
Last Update Posted : March 13, 2020
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Tracking Information
First Submitted Date  ICMJE February 22, 2019
First Posted Date  ICMJE February 25, 2019
Last Update Posted Date March 13, 2020
Actual Study Start Date  ICMJE March 4, 2020
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 22, 2019)
  • 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
  • Feasibility, as measured by the number of participants recruited [ Time Frame: Post-intervention, 3 months ]
    Feasibility, as measured by the number of participants recruited
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 12, 2019)
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: Pre- and post-intervention, 3 months ]
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
Original Secondary Outcome Measures  ICMJE
 (submitted: February 22, 2019)
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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Developing a Pain Identification and Communication Toolkit
Official Title  ICMJE Developing a Pain Identification and Communication Toolkit for Family Caregivers of Persons With Dementia
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE
  • Dementia
  • Chronic Pain
Intervention  ICMJE
  • 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.
  • Behavioral: Information Pamphlet
    Pamphlet with information about pain and dementia and links to Alzheimer's Association
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: PICT Workbook
  • Active Comparator: Information Pamphlet
    Informational pamphlet about pain in dementia and a link to the Alzheimer's Association website.
    Intervention: Behavioral: Information Pamphlet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 12, 2019)
60
Original Estimated Enrollment  ICMJE
 (submitted: February 22, 2019)
80
Estimated Study Completion Date  ICMJE February 2021
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 89 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sylvia Lee, BA 646-962-5884 syl2006@med.cornell.edu
Contact: Patricia Kim, MA 212-746-1758 pak2020@med.cornell.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03853291
Other Study ID Numbers  ICMJE 1811019718
3P30AG022845-15S1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Weill Medical College of Cornell University
Study Sponsor  ICMJE Weill Medical College of Cornell University
Collaborators  ICMJE National Institute on Aging (NIA)
Investigators  ICMJE
Principal Investigator: Cary Reid, MD/PhD Weill Cornell Medicine
Principal Investigator: Catherine Riffin, PhD Weill Cornell Medicine
Principal Investigator: Karl Pillemer, PhD Cornell University
PRS Account Weill Medical College of Cornell University
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP