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

Not Applicable

Completed

• Conditions: Postural Orthostatic Tachycardia Syndrome

• Registration Number: NCT05454137
• Lead Sponsor: University of Arizona

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-07
• Study First Submitted QC: 2022-07-07
• Study First Posted: 2022-07-12
• Study Start: 2023-11-01
• Primary Completion: 2024-08-01
• Status Verified: 2024-12
• Study Completion: 2024-12-01
• Last Update Submitted: 2025-02-28
• Last Update Posted: 2025-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in COMPASS overall score	Baseline and 4 months	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	Baseline and 4 months	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

Trial Locations

Locations (1)

Banner University Medical Center; 🇺🇸 Tucson, Arizona, United States