Ignite Creation Date:
2024-05-06 @ 5:52 PM
Last Modification Date:
2024-10-26 @ 2:37 PM
Study NCT ID:
NCT05464095
Status:
RECRUITING
Last Update Posted:
2023-10-03
First Post:
2022-07-15
Brief Title:
The MObile Health InterVEntion in Pulmonary Arterial Hypertension MOVE PAH Study
Sponsor:
Vanderbilt University Medical Center
Organization:
Vanderbilt University Medical Center
Study Overview
Official Title:
The MObile Health InterVEntion in Pulmonary Arterial Hypertension MOVE PAH Study
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MOVE PAH
Brief Summary:
Patients with pulmonary arterial hypertension PAH have reduced health related quality of life HRQOL and impaired exercise capacity Despite fourteen approved therapies most patients die within ten years Increasing physical activity is highly efficacious in PAH resulting in six-minute walk distance 6MWD and HRQOL improvement that often exceeds the effect of medications Prior activity studies required inpatient rehabilitation which is impractical hard to sustain and poorly scalable to a rare disease
The Investigators propose a randomized trial of smart texts versus usual care for 6 months The Investigators will randomize 100 PAH patients to the mHealth intervention or usual care The Investigators will test the effect of a text-based mHealth intervention on HRQOL in PAH using the PAH-specific emPHasis-10 questionnaire The Investigators will also test the effect of an mHealth intervention on exercise capacity measured by a supervised home-based 6MWD test Finally the Investigators will examine the effect of the intervention on time to clinical worsening composite of PAH therapy escalation PAH hospitalization and death one year after randomization
The Investigators propose a randomized trial of smart texts versus usual care for 6 months The Investigators will randomize 100 PAH patients to the mHealth intervention or usual care The Investigators will test the effect of a text-based mHealth intervention on HRQOL in PAH using the PAH-specific emPHasis-10 questionnaire The Investigators will also test the effect of an mHealth intervention on exercise capacity measured by a supervised home-based 6MWD test Finally the Investigators will examine the effect of the intervention on time to clinical worsening composite of PAH therapy escalation PAH hospitalization and death one year after randomization
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HL158941 | OTHER_GRANT | NHLBI | None |