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
1 other identifier
interventional
100
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 5, 2023
CompletedFirst Submitted
Initial submission to the registry
June 1, 2023
CompletedFirst Posted
Study publicly available on registry
June 18, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedJune 18, 2023
June 1, 2023
1.7 years
June 1, 2023
June 10, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Social support
Change from Baseline social support at six months
Activity ability
Change from Baseline activity ability at six months
Pulmonary Hypertension Quality of life
Change from Baseline quality of life at six months
Study Arms (2)
Web-based health care program
EXPERIMENTALWe 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.
Usual care
NO INTERVENTIONusual care
Interventions
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.
Eligibility Criteria
You may qualify if:
- At least 20 years old, diagnosed by clinical specialists as patients with pulmonary hypertension (Group1 and Group 4)
- Clear consciousness, able to communicate in Mandarin and Taiwanese, with normal hearing
- Those who have internet or mobile internet at home
- Adults without mental illness
- No alcohol or drug abusers.
You may not qualify if:
- \. critical disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tri-Service General Hospital
Taipei, Taiwan, Taipei, 114, Taiwan
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 1, 2023
First Posted
June 18, 2023
Study Start
May 5, 2023
Primary Completion
December 31, 2024
Study Completion
December 31, 2024
Last Updated
June 18, 2023
Record last verified: 2023-06