NCT05908019

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

June 1, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 18, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

June 18, 2023

Status Verified

June 1, 2023

Enrollment Period

1.7 years

First QC Date

June 1, 2023

Last Update Submit

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

EXPERIMENTAL

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

Usual care

NO INTERVENTION

usual 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.

Web-based health care program

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

RECRUITING

Central Study Contacts

Chen miao-yi, PhD Stusent

CONTACT

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

Locations