N/A
Completed N=26
Deployment of American Heart Association Heart Failure Protocols and Content Within the Intel® Health Guide System
Source: ClinicalTrials.gov NCT01275846 ↗Enrolled (actual)
26
Serious AEs
50.0%
Results posted
Mar 2022
Primary outcomePrimary: Percentage of Days Participants Measured Vitals and Completed Protocol Sessions — 88 percentage of days
Summary
This purposed of this study is to ascertain if the implementation of remote patient management systems utilizing American Heart Association (AHA) guideline-based heart failure protocols and educational content can improve the management of patients with congestive heart failure.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Days Participants Measured Vitals and Completed Protocol Sessions |
88 | — |
| PRIMARY Percentage of Health Sessions That Patients Measured and Recorded Vitals |
77 | — |
| SECONDARY Patient Quality of Life Using the Kansas City Cardiomyopathy Questionnaire (KCCQ) Mean Clinical Summary Score Change |
50.74; 51.69; 65.36 | — |
| SECONDARY Patient Quality of Life Using the Kansas City Cardiomyopathy Questionnaire (KCCQ) Mean Overall Score Change |
48.74; 49.84; 63.38 | — |
Eligibility Criteria
Inclusion Criteria
- Patient has a diagnosis of Heart Failure NYHA and is currently in functional class II- IV status.
- Patient has been hospitalized for an episode of acute HF decompensation within the last 30 days.
- Patients with other co-morbidities such as atrial fibrillation, diabetes, coronary artery disease, COPD, hypertension, may be included in this evaluation. These conditions shall be documented during enrollment.
- Have telephone line or broadband internet availability to connect Intel® Health Guide.
- Are physically and mentally capable to complete the monitoring process or have a caregiver capable of assisting in the use of the Intel® Health Guide.
- Will be willing and able to sign an informed consent form to participate in this evaluation for a duration of 60 days.
- Live within a reasonable distance (30 miles or less) from the institution.
Exclusion Criteria
- Have a life expectancy of less than six months.
- Live in a nursing home or other multi-member assisted living facility.
- Intend to be away from their home for more than 2 weeks (14 days) total during the 60 days.
- Are unable to read English at a minimum 5th grade level.
- Do not live within a reasonable distance (30 miles or less) from the institution.
Data sourced from ClinicalTrials.gov (NCT01275846). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.