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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)

Primary Purpose

Web-based Health Care Program

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Web-based health care program
Sponsored by
National Defense Medical Center, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Web-based Health Care Program

Eligibility Criteria

20 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 1. critical disease

Sites / Locations

  • Tri-Service General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Web-based health care program

Usual care

Arm Description

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.

usual care

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Activity ability
6 Minute walk test, 6MWD
Pulmonary Hypertension Quality of life
The Cambridge Pulmonary Hypertension Outcome Review, (CAMPHOR). The 5-point Likert scale higher scores mean a better outcome.

Full Information

First Posted
June 1, 2023
Last Updated
June 10, 2023
Sponsor
National Defense Medical Center, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT05908019
Brief 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.
Acronym
PAH
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.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 5, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Defense Medical Center, Taiwan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Web-based Health Care Program

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Web-based health care program
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
usual care
Intervention Type
Other
Intervention Name(s)
Web-based health care program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pulmonary Arterial Hypertension Symptom
Description
Pulmonary Arterial Hypertension Symptom Interference Scale, PAHSS, The 10-point Likert scale higher scores mean a worse outcome.
Time Frame
Change from Baseline pulmonary Arterial Hypertension Symptom at six months
Secondary Outcome Measure Information:
Title
Social support
Description
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.
Time Frame
Change from Baseline social support at six months
Title
Activity ability
Description
6 Minute walk test, 6MWD
Time Frame
Change from Baseline activity ability at six months
Title
Pulmonary Hypertension Quality of life
Description
The Cambridge Pulmonary Hypertension Outcome Review, (CAMPHOR). The 5-point Likert scale higher scores mean a better outcome.
Time Frame
Change from Baseline quality of life at six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 1. critical disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chen miao-yi, PhD Stusent
Phone
0955762820
Email
miaoyi820@gmail.com
Facility Information:
Facility Name
Tri-Service General Hospital
City
Taipei, Taiwan
State/Province
Taipei
ZIP/Postal Code
114
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chen Miao-Yi, PhD student
Phone
0955762820
Email
miaoyi820@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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.

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