Web-based Health Care ProgramPAHNCT05908019
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.
A study testing Web-based health care program in people with Web-based Health Care Program, run by National Defense Medical Center, Taiwan at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Web-based Health Care Program
- What is being tested?
- Web-based health care program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 5 May 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 1. critical disease
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Tri-Service General Hospital
Taipei, Taiwan, Taipei, 114
Chen Miao-Yi, PhD student, 0955762820, miaoyi820@gmail.com
About this study
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.
- Conditions
- Web-based Health Care Program
- Being tested
- Web-based health care program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-based health care programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Web-based health care program |
| Usual care | No intervention | usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary Arterial Hypertension Symptom
Pulmonary Arterial Hypertension Symptom Interference Scale, PAHSS, The 10-point Likert scale higher scores mean a worse outcome.
Measured: Change from Baseline pulmonary Arterial Hypertension Symptom at six months
Secondary outcomes (3)
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.
Measured: Change from Baseline social support at six months
Activity ability
6 Minute walk test, 6MWD
Measured: 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.
Measured: Change from Baseline quality of life at six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start5 May 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Web-based Health Care ProgramStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Defense Medical Center, Taiwan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miao-Yi Chen, National Defense Medical Center, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05908019
- Sponsor's protocol ID
- NDMC
- Acronym
- PAH
- Status last verified
- Jun 2023
- First submitted
- 1 Jun 2023
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05908019
- Acronym / sponsor ID
- PAH / NDMC
- Conditions
- Web-based Health Care Program
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Defense Medical Center, TaiwanUniversity, hospital or other
- Study start
- 5 May 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Web-based health care program | Experimental | Other: Web-based health care programWe 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 intervention | –usual care |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- 1. critical disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Web-based health care programAccording 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. | Other | Web-based health care program |
Primary outcome
Pulmonary Arterial Hypertension Symptom
Time frame: 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.
3 secondary outcomes
Social support
Time frame: Change from Baseline social support at six months
Activity ability
Time frame: Change from Baseline activity ability at six months
Pulmonary Hypertension Quality of life
Time frame: Change from Baseline quality of life at six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web-based health care program in people with Web-based Health Care Program, run by National Defense Medical Center, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chen miao-yi, PhD Stusent (0955762820, miaoyi820@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary Arterial Hypertension Symptom (time frame: Change from Baseline pulmonary Arterial Hypertension Symptom at six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2023.