search
Back to results

A Shared Medical Appointment Intervention for Quality of Life Improvement in POTS

Primary Purpose

Postural Orthostatic Tachycardia Syndrome

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Shared medical appointment
Sponsored by
University of Arizona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postural Orthostatic Tachycardia Syndrome

Eligibility Criteria

21 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients with a physician diagnosis of POTS

Exclusion Criteria:

  • patients with uncontrolled psychiatric disease
  • patients with uncontrolled medical illness including recent myocardial infarction, stroke, and active malignancy
  • non-English speakers as the group intervention will be delivered in English
  • pregnant women

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    participate in shared medical appointment

    Do not participate in shared medical appointment

    Arm Description

    The POTS shared medical appointment will occur once monthly for four months. Each visit will last 1.5 hours. The group will meet in our clinic group space and lifestyle management therapies will be taught by a physician and another provider ie occupational therapist, dietician etc

    participants will only have one-on-one traditional visit with the physician

    Outcomes

    Primary Outcome Measures

    Recruitment and retention rate
    Percentage of participants who consent to study participation, attend sessions, and complete the program and scheduled outcome assessments

    Secondary Outcome Measures

    Change in COMPASS overall score
    The Composite Autonomic Symptom Score is a self-assessment of autonomic function: orthostatic intolerance, vasomotor, secretomotor, gastrointestinal, bladder, and pupillomotor.
    Change on Short Form Survey (SF-36) overall score
    The 36-Item Short Form Survey (SF-36), is a self assessment of vitality, physical functioning, bodily pain, health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health

    Full Information

    First Posted
    July 7, 2022
    Last Updated
    November 1, 2022
    Sponsor
    University of Arizona
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05454137
    Brief Title
    A Shared Medical Appointment Intervention for Quality of Life Improvement in POTS
    Official Title
    Postural Orthostatic Tachycardia Syndrome: A Pilot, Feasibility Study of an Integrative Shared Medical Appointment Intervention
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 1, 2023 (Anticipated)
    Primary Completion Date
    October 1, 2024 (Anticipated)
    Study Completion Date
    October 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Arizona

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Postural orthostatic tachycardia syndrome (POTS) is a clinical syndrome encompassing a myriad of debilitating symptoms that does not have any FDA approved drug therapies. We propose a shared medical appointment intervention where participants will learn lifestyle management therapies and integrative practices that may improve quality of life.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postural Orthostatic Tachycardia Syndrome

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    25 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    participate in shared medical appointment
    Arm Type
    Experimental
    Arm Description
    The POTS shared medical appointment will occur once monthly for four months. Each visit will last 1.5 hours. The group will meet in our clinic group space and lifestyle management therapies will be taught by a physician and another provider ie occupational therapist, dietician etc
    Arm Title
    Do not participate in shared medical appointment
    Arm Type
    No Intervention
    Arm Description
    participants will only have one-on-one traditional visit with the physician
    Intervention Type
    Behavioral
    Intervention Name(s)
    Shared medical appointment
    Intervention Description
    Shared medical appointment
    Primary Outcome Measure Information:
    Title
    Recruitment and retention rate
    Description
    Percentage of participants who consent to study participation, attend sessions, and complete the program and scheduled outcome assessments
    Time Frame
    at 4 months
    Secondary Outcome Measure Information:
    Title
    Change in COMPASS overall score
    Description
    The Composite Autonomic Symptom Score is a self-assessment of autonomic function: orthostatic intolerance, vasomotor, secretomotor, gastrointestinal, bladder, and pupillomotor.
    Time Frame
    Baseline and 4 months
    Title
    Change on Short Form Survey (SF-36) overall score
    Description
    The 36-Item Short Form Survey (SF-36), is a self assessment of vitality, physical functioning, bodily pain, health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health
    Time Frame
    Baseline and 4 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    79 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patients with a physician diagnosis of POTS Exclusion Criteria: patients with uncontrolled psychiatric disease patients with uncontrolled medical illness including recent myocardial infarction, stroke, and active malignancy non-English speakers as the group intervention will be delivered in English pregnant women
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Iniya Rajendran, MD
    Phone
    520-626-2939
    Email
    irajendran@email.arizona.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Talal Moukabary, MD
    Organizational Affiliation
    University of Arizona
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    A Shared Medical Appointment Intervention for Quality of Life Improvement in POTS

    We'll reach out to this number within 24 hrs