The Effects of Pulmonary Hypertension Web-Based Health Care Program on Symptom Management, Social Support, Activity Tolerance, and Quality of Life in Patients With Pulmonary Hypertension. (PAH)

Pulmonary arterial hypertension (PAH) is a chronic disease characterized by an elevation in pulmonary artery pressures and pulmonary vascular resistance. The condition most often is rarely detected, and patients frequently suffer symptoms for several years before being appropriately diagnosed. Patients with PH suffer from several symptoms, such as exertional dyspnea, fatigue, weakness, chest pain, fainting…et al. Pulmonary hypertension is an incurable and progressive disease with complex symptoms and treatments. Patients must learn to deal with their unpredictable future and manage the complex treatments associated with severe adverse effects and need significant changes in lifestyle.

Therefore, it is important to assist patients to develop the ability of symptom management.

Study Overview

• Status: Recruiting
• Conditions: Web-based Health Care Program
• Intervention / Treatment: Other: Web-based health care program

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chen miao-yi, PhD Stusent; Phone Number: 0955762820; Email: miaoyi820@gmail.com

Study Locations

• Taiwan
  • Taipei
    • Taipei, Taiwan, Taipei, Taiwan, 114
      • Recruiting
      • Tri-Service General Hospital
      • Contact: Chen Miao-Yi, PhD student; Phone Number: 0955762820; Email: miaoyi820@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. At least 20 years old, diagnosed by clinical specialists as patients with pulmonary hypertension (Group1 and Group 4)
2. Clear consciousness, able to communicate in Mandarin and Taiwanese, with normal hearing
3. Those who have internet or mobile internet at home
4. Adults without mental illness
5. No alcohol or drug abusers.

Exclusion Criteria:

1. critical disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual care; usual care
Experimental: Web-based health care program; We aim to develop a PAH web-based health care program, and to evaluate the effects of this program on ameliorating social support, self-care ability and active tolerance, and improving symptom distress, anxiety, depression and quality of life in patients with PAH.	Other: Web-based health care program; According to the participants' feedback and recommends, we will modify this program to make it more suitable. In the second and third years, we will conduct a parallel-group, double blind, and block randomization, experimental design study to examine the effectiveness of the Pulmonary Hypertension Web-Based Care Program on the improvements of patients' social support, self-care ability, active tolerance, symptom distress, depression, anxiety and quality of life in patients with PAH.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulmonary Arterial Hypertension Symptom	Pulmonary Arterial Hypertension Symptom Interference Scale, PAHSS, The 10-point Likert scale higher scores mean a worse outcome.	Change from Baseline pulmonary Arterial Hypertension Symptom at six months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Social support	Multidimensional Scale of Perceived Social Support, (MSPSS). The 7-point Likert scale higher scores mean a better outcome.This instrument is 12 questions long and has been widely used and well validated.	Change from Baseline social support at six months
Activity ability	6 Minute walk test, 6MWD	Change from Baseline activity ability at six months
Pulmonary Hypertension Quality of life	The Cambridge Pulmonary Hypertension Outcome Review, (CAMPHOR). The 5-point Likert scale higher scores mean a better outcome.	Change from Baseline quality of life at six months

Collaborators and Investigators

• Sponsor: National Defense Medical Center, Taiwan

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: June 1, 2023
• First Submitted That Met QC Criteria: June 10, 2023
• First Posted (Estimated): June 16, 2023

Study Record Updates

• Last Update Posted (Estimated): June 16, 2023
• Last Update Submitted That Met QC Criteria: June 10, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Hypertension, Pulmonary
• Other Study ID Numbers: NDMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No