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

Postural Orthostatic Tachycardia Syndrome: A Pilot, Feasibility Study of an Integrative Shared Medical Appointment Intervention

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.

Study Overview

• Status: Recruiting
• Conditions: Postural Orthostatic Tachycardia Syndrome
• Intervention / Treatment: Behavioral: Shared medical appointment

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Iniya Rajendran, MD; Phone Number: 520-626-2939; Email: irajendran@email.arizona.edu

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85719
      • Recruiting
      • Banner University Medical Center
      • Contact: Iniya Rajendran

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: participate in shared medical appointment; 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	Behavioral: Shared medical appointment; Shared medical appointment
No Intervention: Do not participate in shared medical appointment; participants will only have one-on-one traditional visit with the physician

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment and retention rate	Percentage of participants who consent to study participation, attend sessions, and complete the program and scheduled outcome assessments	at 4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and 4 months
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	Baseline and 4 months

Collaborators and Investigators

• Sponsor: University of Arizona
• Investigators: Principal Investigator: Talal Moukabary, MD, University of Arizona

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: July 7, 2022
• First Submitted That Met QC Criteria: July 7, 2022
• First Posted (Actual): July 12, 2022

Study Record Updates

• Last Update Posted (Actual): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Nervous System Diseases; Disease; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Autonomic Nervous System Diseases; Primary Dysautonomias; Orthostatic Intolerance; Syndrome; Tachycardia; Postural Orthostatic Tachycardia Syndrome
• Other Study ID Numbers: STUDY00001552

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No