Urban Zen Integrative Therapy for Persons With Pulmonary Hypertension

Not Applicable

Completed

• Conditions: Pulmonary Hypertension; Chronic Disease
• Interventions: Behavioral: Urban Zen Integrative Therapy (UZIT)

• Registration Number: NCT03194438
• Lead Sponsor: Ohio State University

Brief Summary

The primary goal of this study is to determine the feasibility and acceptability of a 6-week multicomponent integrative therapy program, Urban Zen Integrative Therapy (UZIT), for adults with chronic, life-limiting cardiopulmonary disease. The secondary goal is to determine preliminary efficacy of UZIT in symptom management. Pulmonary hypertension (PH) presents an excellent model of a severe, life-limiting cardiopulmonary condition with high symptom burden and poor outcomes suitable for this scientific inquiry. Despite medical and pharmacological advances in the treatment, 50-55% of persons with PH will die within three years after diagnosis. Medical management often involves life-long complex pharmacological treatment requiring high levels of skill, knowledge, and social support. Clusters of bothersome symptoms such as chest pain, anxiety, insomnia, dyspnea, and fatigue can overwhelm patients' ability to manage daily activities and medication treatment regimens. Side effects of treatment induce additional noxious symptoms. The high prevalence of physical symptoms, depression, and anxiety among adults with PH confirmed in our prior work, can also lead to reduced (HRQoL). A literature search found no published report of complementary, integrative therapy interventions to alleviate symptoms in adults with PH. This study will use a single group repeated-measures design to address the feasibility and acceptability of the intervention and to explore preliminary efficacy.

Detailed Description

This feasibility and acceptability study will use a pre/post intervention (6-weeks UZIT program) mixed-method design with repeated (weekly) measures of a single cohort of 20 patients with PH. This study will also explore preliminary efficacy testing to construct sample size estimates for future randomized control trials. Patients will serve as their controls.

This study will enroll 20 patients from two PH clinics within the Ohio State University Wexner Medical Center (OSUWMC). Patients with PH condition related to the cardiac cause are managed at the OSU Cardiology clinic located at the Ross Heart Hospital. Patients with PH condition related to other causes are managed at the OSU Pulmonary clinic at Martha Morehouse. These inter-professional clinics provide access to a patient population with diverse race/ ethnicity, sex, and age. All eligible patients managed at both PH clinics at OSUWMC will be invited to participate. Patients in both clinics receive standard medical treatments according to institutional and national clinical practice guidelines.

Study Timeline

• Study First Submitted: 2017-06-15
• Study Start: 2017-06-19
• Study First Submitted QC: 2017-06-20
• Study First Posted: 2017-06-21
• Status Verified: 2018-06
• Primary Completion: 2018-06-05
• Study Completion: 2018-06-05
• Last Update Submitted: 2018-06-11
• Last Update Posted: 2018-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
UZIT arm	Urban Zen Integrative Therapy (UZIT)	Multi-modal components integrative therapy intervention program, Urban Zen Integrative Therapy.

Primary Outcome Measures

Name	Time	Method
Change in Pulmonary Arterial Hypertension Symptom Scale - SOB With Exertion	Baseline and 6-week post-intervention	Symptoms assessment and Health-related quality of life assessment. We focused on the shortness of breath. The minimum and maximum scores are 0 and 10, respectively. A higher score indicates the worst outcome.Measured at baseline and 6-weeks post-intervention for comparision

Secondary Outcome Measures

Name	Time	Method
Change in Cambridge Pulmonary Hypertension Outcome Review.	Baseline and 6-week post-intervention	This instrument was used to measure the overall Health-related quality of life with multiple domains. We focused on the Symptom Burden domain.; The minimum and maximum scores range from "0" to "25", indicating "good" and "poor" symptom burden, respectively.; The scale of the change score indicates the level of MID (minimum importance difference). If the score is more significant than 2.0 MID, the intervention makes a minimal level of importance in their quality of life perception.; Measurements were taken at baseline and 6-weeks post-intervention for comparision.

Trial Locations

Locations (1)

The Ohio State University Ross Heart Hospital; 🇺🇸 Columbus, Ohio, United States