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NCT05454137 Clinical Trial

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

Postural Orthostatic Tachycardia Syndrome Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05454137
Other study ID # STUDY00001552
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 1, 2023
Est. completion date October 1, 2024

Study information
Verified date December 2023
Source University of Arizona
Contact Iniya Rajendran, MD
Phone 520-626-2939
Email irajendran@email.arizona.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 25
Est. completion date October 1, 2024
Est. primary completion date October 1, 2024
Accepts healthy volunteers No
Gender All
Age group 21 Years to 79 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Behavioral:
• Shared medical appointment
Shared medical appointment

Locations
Country Name City State
United States Banner University Medical Center Tucson Arizona

Sponsors (1)
Lead Sponsor Collaborator
University of Arizona

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
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