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
About this trial
This is an interventional treatment trial for Postural Orthostatic Tachycardia Syndrome
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
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
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
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