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Trial record 42 of 1352 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

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.

Condition or disease Intervention/treatment Phase
End Stage Renal Disease Other: Palliative care consultation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Telemedicine Facilitated Palliative Care Consultations in Rural Dialysis Units
Actual Study Start Date : October 11, 2018
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Other: Palliative care consultation
A palliative care consultation will occur via telemedicine with patients receiving maintenance dialysis.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03744117


Contacts
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Contact: Katharine L Cheung, MD, PhD 802-656-8248 klcheung@med.uvm.edu

Locations
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United States, Vermont
University of Vermont Medical Center Recruiting
Burlington, Vermont, United States, 05401
Contact: Katharine L Cheung    802-656-8248    klcheung@med.uvm.edu   
Sponsors and Collaborators
University of Vermont
Icahn School of Medicine at Mount Sinai

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Responsible Party: Katharine Cheung, Primary Investigator, Assistant Professor of Medicine, University of Vermont
ClinicalTrials.gov Identifier: NCT03744117     History of Changes
Other Study ID Numbers: CHRMS 19-0081
First Posted: November 16, 2018    Key Record Dates
Last Update Posted: November 16, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Katharine Cheung, University of Vermont:
dialysis
end-stage kidney disease
supportive care
palliative care
rural health
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency