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The MObile Health InterVEntion in Pulmonary Arterial Hypertension (MOVE PAH) Study (MOVE PAH))

Primary Purpose

Pulmonary Arterial Hypertension

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
mHealth Intervention
Usual Care
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Arterial Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adults aged 18 or older.
  • Diagnosed with idiopathic, heritable, or associated (connective tissue disease, drugs, or toxins) pulmonary arterial hypertension (PAH), or PAH due to simple congenital heart disease (i.e. atrial septal defect).
  • WHO functional class I-III
  • Stable PAH-specific medication regimen for three months prior to enrollment. Subjects with only a single diuretic adjustment in the prior three months will be included. Adjustments in IV prostacyclin for side effect management are allowed.
  • Forced vital capacity >65% predicted with no or minimal interstitial lung disease based on reviews of imaging studies by PI and medical monitor.

Exclusion Criteria:

  • Prohibited from normal activity due to wheelchair bound status, bed bound status, reliance on a cane/walker, activity-limiting angina, activity-limiting osteoarthritis, or other condition that limits activity.
  • Pregnancy
  • Diagnosis of PAH etiology other than idiopathic, heritable, or associated.
  • Functional class IV heart failure
  • Requirement of > 2 diuretic adjustment in the prior three months.
  • Preferred form of activity is not measured by an activity tracker (swimming, yoga, ice skating, stair master, or activities on wheels such as bicycling or rollerblading).

Sites / Locations

  • Vanderbilt University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

mHealth Intervention

Usual Care

Arm Description

Patients will be randomized to the mHealth texting platform, which are messages designed to facilitate self-awareness, reinforce step targets, and link physical activity with a reward or memorable cue.

Routine medical care

Outcomes

Primary Outcome Measures

Change in Quality of Life as measured by the Short Form Survey (SF-36)
The SF-36 is a 36 item scale, which measures eight domains of health status: physical functioning (10 items); physical role limitations (four items); bodily pain (two items); general health perceptions (five items); energy/vitality (four items); social functioning (two items); emotional role limitations (three items) and mental health (five items). A scoring algorithm is used to convert the raw scores into the eight dimensions listed above. The scores are transformed to range from zero where the respondent has the worst possible health to 100 where the respondent is in the best possible health.
Change in Quality of Life as measured by the emPHasis-10
The emPHasis-10 is a short and easy questionnaire that consists of 10 items that address breathlessness, fatigue, control, and confidence. Each item is scored on a semantic differential six-point scale (0-5), with contrasting adjectives at each end. A total emPHasis-10 score is derived using simple aggregation of the 10 items. emPHasis-10 scores range from 0 to 50, higher scores indicate worse quality of life.

Secondary Outcome Measures

Change in meters walked from baseline to 24 weeks in six minute walk distance (meters)
The change in meters walked for the six-minute walk distance from baseline to week 24. the six-minute walk test is a measure of functional status or fitness
Change in rated dyspnea from baseline to 24 weeks using the Borg Dyspnea Score
The change in Borg Dyspnea Score associated with the six-minute walk distance from baseline to week 24. The Borg Dyspnea Scale is a 0 to 10 rated numerical score (the higher the score = worsening dyspnea) used to measure dyspnea as reported by the patient during submaximal exercise and is routinely administered during six-minute walk testing (6MWT), one of the most common and frequently used measures to assess disease severity in PAH.
Change in resting heart rate from baseline to 24 weeks (beats per minute)
Monitored regularly using activity tracking device (per second when active, per 5 seconds when inactive). Subject's resting and peak exercise heart rate will also be recorded at baseline and week 24. Targets exercise capacity. Heart rate is expressed as beats per minute.
Time to clinical worsening
To assess the effect of a mHealth intervention or no intervention on a composite outcome of PAH-related hospitalization, medication regimen escalation, and all-cause mortality at one year after randomization. Clinical worsening events are defined as death (all causes), hospitalizations due to worsening pulmonary arterial hypertension (PAH), and initiation of an inhaled or infused prostacyclin (PGI2) for the treatment of worsening PAH.

Full Information

First Posted
July 15, 2022
Last Updated
September 29, 2023
Sponsor
Vanderbilt University Medical Center
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT05464095
Brief Title
The MObile Health InterVEntion in Pulmonary Arterial Hypertension (MOVE PAH) Study
Acronym
MOVE PAH)
Official Title
The MObile Health InterVEntion in Pulmonary Arterial Hypertension (MOVE PAH) Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
September 1, 2026 (Anticipated)
Study Completion Date
August 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Arterial Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, single-blinded, parallel group, Phase II study of 100 subjects with PAH. Eligible subjects will be randomly assigned to receive the mHealth intervention or not for twenty-four weeks.
Masking
InvestigatorOutcomes Assessor
Masking Description
The investigators and study coordinators will be blinded to treatment arms
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
mHealth Intervention
Arm Type
Active Comparator
Arm Description
Patients will be randomized to the mHealth texting platform, which are messages designed to facilitate self-awareness, reinforce step targets, and link physical activity with a reward or memorable cue.
Arm Title
Usual Care
Arm Type
Other
Arm Description
Routine medical care
Intervention Type
Device
Intervention Name(s)
mHealth Intervention
Intervention Description
The Health Insurance Portability and Accountability Act (HIPPA) compliant texting platform is linked to the Fitbit Application Program Interface. Real time activity data will be transmitted from the subject's smartphone to the mHealth platform via cellular network. Participants assigned to the texting arm will receive 3 texts/day in sync with their preferred morning, lunch, and evening leisure schedule, which is defined at enrollment. These texts will use personal, disease-specific, and provider information to deliver 2 types of messages customized to the current step count and sent in equal proportion. Messages are designed to facilitate self-awareness, reinforce step targets, and link physical activity with a reward or memorable cue.
Intervention Type
Device
Intervention Name(s)
Usual Care
Intervention Description
The HIPPA-compliant texting platform is linked to the Fitbit Application Program Interface. Real-time activity data will be transmitted from the subject's smartphone to the mHealth platform via cellular network.
Primary Outcome Measure Information:
Title
Change in Quality of Life as measured by the Short Form Survey (SF-36)
Description
The SF-36 is a 36 item scale, which measures eight domains of health status: physical functioning (10 items); physical role limitations (four items); bodily pain (two items); general health perceptions (five items); energy/vitality (four items); social functioning (two items); emotional role limitations (three items) and mental health (five items). A scoring algorithm is used to convert the raw scores into the eight dimensions listed above. The scores are transformed to range from zero where the respondent has the worst possible health to 100 where the respondent is in the best possible health.
Time Frame
Baseline to 24 weeks
Title
Change in Quality of Life as measured by the emPHasis-10
Description
The emPHasis-10 is a short and easy questionnaire that consists of 10 items that address breathlessness, fatigue, control, and confidence. Each item is scored on a semantic differential six-point scale (0-5), with contrasting adjectives at each end. A total emPHasis-10 score is derived using simple aggregation of the 10 items. emPHasis-10 scores range from 0 to 50, higher scores indicate worse quality of life.
Time Frame
Baseline to 24 weeks
Secondary Outcome Measure Information:
Title
Change in meters walked from baseline to 24 weeks in six minute walk distance (meters)
Description
The change in meters walked for the six-minute walk distance from baseline to week 24. the six-minute walk test is a measure of functional status or fitness
Time Frame
baseline and 24 weeks
Title
Change in rated dyspnea from baseline to 24 weeks using the Borg Dyspnea Score
Description
The change in Borg Dyspnea Score associated with the six-minute walk distance from baseline to week 24. The Borg Dyspnea Scale is a 0 to 10 rated numerical score (the higher the score = worsening dyspnea) used to measure dyspnea as reported by the patient during submaximal exercise and is routinely administered during six-minute walk testing (6MWT), one of the most common and frequently used measures to assess disease severity in PAH.
Time Frame
baseline and 24 weeks
Title
Change in resting heart rate from baseline to 24 weeks (beats per minute)
Description
Monitored regularly using activity tracking device (per second when active, per 5 seconds when inactive). Subject's resting and peak exercise heart rate will also be recorded at baseline and week 24. Targets exercise capacity. Heart rate is expressed as beats per minute.
Time Frame
baseline and 24 weeks
Title
Time to clinical worsening
Description
To assess the effect of a mHealth intervention or no intervention on a composite outcome of PAH-related hospitalization, medication regimen escalation, and all-cause mortality at one year after randomization. Clinical worsening events are defined as death (all causes), hospitalizations due to worsening pulmonary arterial hypertension (PAH), and initiation of an inhaled or infused prostacyclin (PGI2) for the treatment of worsening PAH.
Time Frame
baseline to one year after randomization.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults aged 18 or older. Diagnosed with idiopathic, heritable, or associated (connective tissue disease, drugs, or toxins) pulmonary arterial hypertension (PAH), or PAH due to simple congenital heart disease (i.e. atrial septal defect). WHO functional class I-III Stable PAH-specific medication regimen for three months prior to enrollment. Subjects with only a single diuretic adjustment in the prior three months will be included. Adjustments in IV prostacyclin for side effect management are allowed. Forced vital capacity >65% predicted with no or minimal interstitial lung disease based on reviews of imaging studies by PI and medical monitor. Exclusion Criteria: Prohibited from normal activity due to wheelchair bound status, bed bound status, reliance on a cane/walker, activity-limiting angina, activity-limiting osteoarthritis, or other condition that limits activity. Pregnancy Diagnosis of PAH etiology other than idiopathic, heritable, or associated. Functional class IV heart failure Requirement of > 2 diuretic adjustment in the prior three months. Preferred form of activity is not measured by an activity tracker (swimming, yoga, ice skating, stair master, or activities on wheels such as bicycling or rollerblading).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alisha Lindsey, RT
Phone
615-322-3412
Email
alisha.lindsey@vumc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Evan Brittain, MD
Phone
615-322-2318
Email
evan.brittain@vumc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evan Brittain, MD
Organizational Affiliation
Vanderbilt Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kelly Burke, RN
Email
kelly.burke@vumc.org

12. IPD Sharing Statement

Plan to Share IPD
No

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The MObile Health InterVEntion in Pulmonary Arterial Hypertension (MOVE PAH) Study

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