NCT02689687

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable heart-failure

Timeline
Completed

Started Feb 2016

Shorter than P25 for not_applicable heart-failure

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2016

Completed
4 days until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 24, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

May 11, 2016

Status Verified

February 1, 2016

Enrollment Period

3 months

First QC Date

January 28, 2016

Last Update Submit

May 10, 2016

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

  • Number of patients successfully setup on the remote monitoring devices

    30 days

Secondary Outcomes (2)

  • All-cause readmission rate

    30 days

  • Proportion of weight gain alerts that are opened

    30 days

Study Arms (1)

Intervention

EXPERIMENTAL

All participants will be (1) given an electronic pill bottle for their diuretic and a Bluetooth scale; (2) asked to provide the coordinator with name and contact information of a family member or friend to serve as a support partner; (3) will be assigned a 2-digit number to be used as part of the lottery-based engagement incentives in which eligibility to win will be conditional on medication adherence and registering a weight measurement; and, (4) will determine their preferences for Way to Health platform communication methods during the study.

Behavioral: Support partnerBehavioral: Engagement incentivesBehavioral: Electronic pill bottleBehavioral: Bluetooth scale

Interventions

Support partnerBEHAVIORAL

Participants will identify a support partner who will be contacted if the participant is non-adherent to their diuretic and/or weighing-in.

Intervention
Engagement incentivesBEHAVIORAL

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.

Intervention
Electronic pill bottleBEHAVIORAL

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.

Intervention
Bluetooth scaleBEHAVIORAL

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.

Intervention

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Kevin G Volpp, MD, PhD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

  • David A Asch, MD, MBA

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2016

First Posted

February 24, 2016

Study Start

February 1, 2016

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

May 11, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share