Conference: 2017 PH Professional Network Symposium
Release Date: 10.06.2017
Presentation Type: Abstracts
File Download: 2017 PHPN Abstract 1035
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Abstract presented at the 2017 PH Professional Network Symposium held in Bethesda, MD on October 5-7, 2017
To describe research study plan testing feasibility, acceptability and preliminary efficacy of an integrative program for symptom management in persons with pulmonary hypertension (PH). Evaluating preliminary efficacy of a multi-modal behavioral intervention, Urban Zen Integrative Therapy (UZIT), requires documentation of the intervention fidelity. Consistent delivery of the intervention dose is essential to the integrity of any research design, but of particular concern in research study testing integrative therapy intervention. Proper description and delineation of intervention fidelity assessment is necessary to ensure consistent treatment delivery. This poster will present plans for measuring study’s feasibility, acceptability, and intervention fidelity.
Pulmonary Hypertension (PH) is a progressive and debilitating chronic cardiopulmonary condition and serves as an excellent model for symptom management intervention development and testing. Elevated pulmonary pressure and associated high symptom burden can impair patients’ ability to manage and adhere to medical treatments leading to reduced quality of life. Integrative approaches to symptom management are urgently needed. Many integrative approaches have shown benefit in symptom alleviation in chronic conditions such as cancer and heart disease, and may have therapeutic benefits in PH. A patient-centered, pragmatic integrative approach to symptom treatment can provide holistic management without added side effects. The purpose of this mixed-methods pilot study is to determine the feasibility, acceptability, and preliminary efficacy of a 6-week integrative therapy program, UZIT among community-dwelling adults with PH.
Feasibility will be determined by 1) Recruitment rate (>40% recruited from those approached), 2) Enrollment rate (>2 /month), 3) Home practice (> 1/week), and 4) retention rate (>70% of participants remain). Acceptability will be determined by 1) Participants’ evaluation of the UZIT program (composite mean System Usability Scale score > 5, scale 1-7), 2) Session completion rate (83% attendance by the participants retained at the study end). UZIT intervention fidelity will focus on consistency of intervention delivery and intervention dose which will address: 1) research intervention protocol, 2) interventionists’ competency training, 3) quality audit, and 4) research process evaluation.
We will enroll a single cohort of 20 PH participants at an academic medical center. UZIT intervention will include four integrative modalities: essential oil, gentle body movement/restorative pose, body-awareness meditation, and Reiki. Trained UZIT therapists will provide treatments tailored to patients’ symptoms and physical capability, however, within the bounds of the research protocol. Study field notes, semi-structured interviews, and daily symptom diaries will provide qualitative description of symptoms and UZIT acceptability and constant comparison. Intervention sessions will be remotely video recorded and examined for fidelity.
To be determined.
Implementation of behavioral intervention research is challenged by many threats to study’s internal validity. Mind-body integrative therapy with multi-modal components adds further complexity to the scientific testing standards. With the goal of establishing study feasibility and acceptability, consistent intervention delivery is paramount to optimize scientific rigor. Future efficacy testing of UZIT for symptom management in PH will rely on this scientific standard. If feasible and acceptable to PH patients, this intervention has the potential to mitigate the bothersome symptoms inherent in PH and improve patients’ quality of life.