PAH: 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.

Sponsor
National Defense Medical Center, Taiwan (Other)
Overall Status
Recruiting
CT.gov ID
NCT05908019
Collaborator
(none)
100
1
2
19.9
5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Web-based health care program
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
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.
Actual Study Start Date :
May 5, 2023
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
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.

No Intervention: Usual care

usual care

Outcome Measures

Primary Outcome Measures

  1. Pulmonary Arterial Hypertension Symptom [Change from Baseline pulmonary Arterial Hypertension Symptom at six months]

    Pulmonary Arterial Hypertension Symptom Interference Scale, PAHSS, The 10-point Likert scale higher scores mean a worse outcome.

Secondary Outcome Measures

  1. Social support [Change from Baseline social support at six months]

    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.

  2. Activity ability [Change from Baseline activity ability at six months]

    6 Minute walk test, 6MWD

  3. Pulmonary Hypertension Quality of life [Change from Baseline quality of life at six months]

    The Cambridge Pulmonary Hypertension Outcome Review, (CAMPHOR). The 5-point Likert scale higher scores mean a better outcome.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tri-Service General Hospital Taipei, Taiwan Taipei Taiwan 114

Sponsors and Collaborators

  • National Defense Medical Center, Taiwan

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Miao-Yi Chen, Principal Investigator, National Defense Medical Center, Taiwan
ClinicalTrials.gov Identifier:
NCT05908019
Other Study ID Numbers:
  • NDMC
First Posted:
Jun 18, 2023
Last Update Posted:
Jun 18, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 18, 2023