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OpenTrials
Completed

NCT Number: NCT05454137

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

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.

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Key information

Conditions

Postural Orthostatic Tachycardia Syndrome Autonomic Nervous System Diseases Nervous System Diseases Orthostatic Intolerance Primary Dysautonomias

Age range

21 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Banner University Medical Center

Tucson, Arizona, 85719, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Shared medical appointment

Behavioral

Shared medical appointment

Primary outcomes

  1. Recruitment and retention rate

    Time frame: at 4 months

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

Secondary outcomes

  1. Change in COMPASS overall score

    Time frame: Baseline and 4 months

    The Composite Autonomic Symptom Score is a self-assessment of autonomic function: orthostatic intolerance, vasomotor, secretomotor, gastrointestinal, bladder, and pupillomotor.

  2. Change on Short Form Survey (SF-36) overall score

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 12, 2022
Registry last updated
Mar 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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