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

NCT05454137 | Completed

• 1 other identifier: STUDY00001552
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Postural Orthostatic Tachycardia Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in COMPASS overall score

  Baseline and 4 months

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

  Baseline and 4 months

Study Arms (2)

participate in shared medical appointment

EXPERIMENTAL

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

Do not participate in shared medical appointment

NO INTERVENTION

participants will only have one-on-one traditional visit with the physician

Interventions

Shared medical appointment BEHAVIORAL

Shared medical appointment

participate in shared medical appointment

Eligibility Criteria

• Age: 21 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with a physician diagnosis of POTS

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

Banner University Medical Center

Tucson, Arizona, 85719, United States

Location

MeSH Terms

Conditions

Postural Orthostatic Tachycardia Syndrome

Interventions

Shared Medical Appointments

Condition Hierarchy (Ancestors)

Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Appointments and Schedules; Organization and Administration; Health Services Administration; Practice Management, Medical; Practice Management; Professional Practice

Study Officials

• Talal Moukabary, MD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2022
• First Posted: July 12, 2022
• Study Start: November 1, 2023
• Primary Completion: August 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 5, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)