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

Study Overview
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Brief Summary
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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.

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

Conditions
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Postural Orthostatic Tachycardia Syndrome

Intervention / Treatment
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* Behavioral: Shared medical appointment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 |