Compliance Feasibility Study for Remote Phase 2 Cardiac Rehabilitation
Compliance Feasibility Study for Remote Phase 2 Cardiac Rehabilitation
Sponsors
Source
St. Louis University
Oversight Info
Has Dmc
No
Is Fda Regulated Drug
No
Is Fda Regulated Device
No
Brief Summary
This study evaluates the compliance of patients in a Phase 2 (outpatient clinic based)
cardiac rehabilitation program, who are offered the opportunity to perform the rehab remotely
(e.g. at home, not at the clinic), using a remote monitor and smart-phone application.
Detailed Description
In spite of the fact that cardiac rehabilitation has been shown to be beneficial to patients
who have had a cardiac event, such as a heart attack, only 5% of eligible patients complete
this program. Some of the reasons cited include limited facility access, travel time and
cost.
We are testing the hypothesis that cardiac rehab compliance will be greater if patients are
offered the opportunity, and associated technology, to perform cardiac rehab anywhere.
Overall Status
Completed
Start Date
2018-03-19
Completion Date
2019-09-30
Primary Completion Date
2019-09-30
Phase
N/A
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
Percentage of patients completing remote rehab program compared to case controls |
Immediately after cardiac rehab completion or stoppage |
Secondary Outcome
Measure |
Time Frame |
|
Six minute walk test compared to case controls |
Immediately after cardiac rehab completion or stoppage |
|
depression score vs case controls |
Immediately after cardiac rehab completion or stoppage |
|
Average number of minutes in exercise rehab compared to case controls |
Immediately after cardiac rehab completion or stoppage |
Enrollment
25
Condition
Intervention
Eligibility
Criteria
Inclusion Criteria:
- referred to SLU cardiac rehab facility
Exclusion Criteria:
- does not own app compatible smart phone
- dementia
- syncope
- valvular disease
- life expectancy < 1 year
- non-English speaking
- unstable angina
- decompensated congestive heart failure
- ventricular arrhythmia
Gender
All
Minimum Age
18 Years
Maximum Age
90 Years
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
Lisa Alderson, MD |
Principal Investigator |
St. Louis University |
Location
Facility |
|
Saint Louis University - SLUCare Saint Louis Missouri 63117 United States |
Location Countries
Country
United States
Verification Date
2019-10-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Principal Investigator
Investigator Affiliation
St. Louis University
Investigator Full Name
Lisa Alderson MD, F.A.C.C.
Investigator Title
Assistant Professor
Keyword
Has Expanded Access
No
Firstreceived Results Date
N/A
Patient Data
Sharing Ipd
No
Ipd Description
no current plan
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Non-Randomized
Intervention Model
Single Group Assignment
Primary Purpose
Health Services Research
Masking
None (Open Label)
Study First Submitted
April 2, 2018
Study First Submitted Qc
April 2, 2018
Study First Posted
April 9, 2018
Last Update Submitted
October 30, 2019
Last Update Submitted Qc
October 30, 2019
Last Update Posted
November 1, 2019
ClinicalTrials.gov processed this data on December 11, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.