Heart Failure
Conditions
Brief summary
This study offers remote monitoring devices for weight and medication adherence, combined with behavioral economic approaches, to patients with congestive heart failure (CHF). This pilot study aims to evaluate the feasibility of enrollment processes and intervention roll-out to inform a randomized controlled trial, to estimate the readmission rate of participants, and to assess if and how managing clinicians respond to weight gain alerts entered into a participant's electronic medical record.
Detailed description
The specific aims of this study are: (1) To leverage access to the University of Pennsylvania Health System (UPHS) CHF clinic, PennChart (electronic medical record system) resources for identifying eligible patients, and the Way to Health (WTH) platform to launch a pilot study that will inform a randomized controlled trial; (2) to evaluate the feasibility of the enrollment processes and intervention roll-out to inform a randomized controlled trial; (3) to estimate the readmission rate of participants; and, (4) to assess if and how managing physicians respond to weight gain alerts entered into participant charts in PennChart. In this pilot study, no randomization will occur and all participants will receive the intervention.
Interventions
BEHAVIORALSupport partner
Participants will identify a support partner who will be contacted if the participant is non-adherent to their diuretic and/or weighing-in.
BEHAVIORALEngagement incentives
Participants will be entered into a daily lottery, for which their participation is contingent on adhering to their diuretic and to weighing-in on the previous day.
BEHAVIORALElectronic pill bottle
Participant adherence to their diuretic will be monitored on a daily basis and participants will be contacted if they are non-adherent to this medication.
BEHAVIORALBluetooth scale
Participant adherence to stepping on their scale will be monitored on a daily basis and participants will be contacted if they are non-adherent to weighing-in. Participant weight gain will also be monitored, and if weight gain exceeds a specific threshold, the managing physician will be notified through the electronic medical record system. Managing providers will also be sent a weekly report of weight measurements.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
University of Pennsylvania
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Discharged to home within the past 30 days from a UPHS hospital with a principal diagnosis of CHF * Aged 18 to 80 years old * Will receive follow-up in a UPHS outpatient clinic by a cardiologist or primary care physician
Exclusion criteria
* Less than 18 years old or older than 80 years old * Will not or cannot provide informed consent * Have a markedly shortened life expectancy (listed for heart transplant, have ventricular assist device, are inotrope dependent, have metastatic cancer, or have dementia) * Have end-stage renal disease * Have a glomerular filtration rate \<25 ml/min * On dialysis * Heart failure is managed with a CardioMEMS monitor * Receiving another remote monitoring/telemedicine intervention * Receiving follow-up care outside of UPHS
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients successfully setup on the remote monitoring devices | 30 days |
Secondary
| Measure | Time frame |
|---|---|
| All-cause readmission rate | 30 days |
| Proportion of weight gain alerts that are opened | 30 days |
Outcome results
None listed