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Trial record 42 of 1368 for:    rural

Tele-palliative Care in Rural Dialysis Patients

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ClinicalTrials.gov Identifier: NCT03744117
Recruitment Status : Recruiting
First Posted : November 16, 2018
Last Update Posted : November 16, 2018
Sponsor:
Collaborator:
Icahn School of Medicine at Mount Sinai
Information provided by (Responsible Party):
Katharine Cheung, University of Vermont

Tracking Information
First Submitted Date  ICMJE November 13, 2018
First Posted Date  ICMJE November 16, 2018
Last Update Posted Date November 16, 2018
Actual Study Start Date  ICMJE October 11, 2018
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 15, 2018)
  • Feasibility will be defined as the 1 month completion rate of the consult from time of participant recruitment to the consult. [ Time Frame: This will be assessed at 18 months. ]
    We will define feasibility as the 1 month completion rate of the consult from time of participant recruitment to the consult.
  • Acceptability :We will measure acceptability of the telemedicine intervention using a 5-point likert scale. [ Time Frame: This will be assessed at 18 months. ]
    We will measure acceptability of the telemedicine intervention using a 5-point likert scale.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 15, 2018)
  • Quality of communication reported by patients:Quality of communication will be measured using an adapted form of the Quality of Communication survey tool. This consists of 6 questions, each with a score of 0-10. [ Time Frame: The survey will be completed within 2 weeks of the intervention. ]
    Quality of communication will be measured using an adapted form of the Quality of Communication survey tool. This consists of 6 questions, each with a score of 0-10.
  • Heard and Understood: Participants will rate on a 5-point scale whether they felt heard and understood during the palliative care consultation. [ Time Frame: This question will be completed within 2 weeks of the intervention. ]
    Participants will rate on a 5-point scale whether they felt heard and understood during the palliative care consultation.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tele-palliative Care in Rural Dialysis Patients
Official Title  ICMJE Telemedicine Facilitated Palliative Care Consultations in Rural Dialysis Units
Brief Summary Telemedicine is an innovative approach that has successfully facilitated palliative care consultations (PCC) in rural settings but not yet in dialysis. In this study, the investigators will deliver telemedicine-facilitated PCC to rural dialysis units leveraging an existing telehealth network.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE End Stage Renal Disease
Intervention  ICMJE Other: Palliative care consultation
A palliative care consultation will occur via telemedicine with patients receiving maintenance dialysis.
Study Arms  ICMJE Experimental: Intervention Arm
There is a single arm in this study. All patients will be assigned to receive the intervention, which is a palliative care consultation delivered by telemedicine.
Intervention: Other: Palliative care consultation
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: November 15, 2018)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2020
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • All patients age 18 and older, receiving maintenance dialysis who are willing and capable of providing informed consent.

Exclusion Criteria:

  • Patients with dementia or other medical conditions that would impair their ability to consent, participate in conversation or complete questionnaires, or patients expected to transfer to a dialysis unit outside of Vermont within 6 months would be excluded.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Katharine L Cheung, MD, PhD 802-656-8248 klcheung@med.uvm.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03744117
Other Study ID Numbers  ICMJE CHRMS 19-0081
Has Data Monitoring Committee Yes
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 Katharine Cheung, University of Vermont
Study Sponsor  ICMJE University of Vermont
Collaborators  ICMJE Icahn School of Medicine at Mount Sinai
Investigators  ICMJE Not Provided
PRS Account University of Vermont
Verification Date November 2018

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