NCT02708654

Brief Summary

Using a 2-arm, randomized controlled trial (RCT) among CHF patients at the University of Pennsylvania Health System (UPHS), to test the effectiveness of applying automated hovering to improve outcomes among CHF patients at high risk of readmission.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
566

participants targeted

Target at P75+ for not_applicable heart-failure

Timeline
Completed

Started May 2016

Longer than P75 for not_applicable heart-failure

Geographic Reach
1 country

1 active site

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

March 10, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 15, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

May 22, 2016

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 7, 2020

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

May 18, 2022

Status Verified

May 1, 2022

Enrollment Period

3.9 years

First QC Date

March 10, 2016

Last Update Submit

May 16, 2022

Conditions

Heart Failure

Keywords

Remote monitoringIncentives

Outcome Measures

Primary Outcomes (1)

  • Hospital readmission rate

    Our primary outcome is time to readmission for any cause.The primary comparison will be the times to events compared between the intervention arm and the usual care arm; that is, the primary hypothesis is whether a series of interventions, adapted to the behavior and outcomes of each particular patient, will reduce readmission rates compared to usual care.

    12 months

Secondary Outcomes (3)

  • Cost

    12 months

  • Medication adherence to diuretic as measured by electronic pill bottle

    12 months

  • Deaths

    12 months

Study Arms (2)

Intervention

EXPERIMENTAL

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.(5) Research coordinators to remotely monitor weight gain thresholds and add alert into the participant's electronic health record for verified weight gain

Behavioral: Electronic pill bottleBehavioral: Bluetooth scaleBehavioral: Support PartnerBehavioral: Engagement incentives

Control

NO INTERVENTION

Participants will receive usual care.

Interventions

Electronic pill bottleBEHAVIORAL

Participant adherence to their diuretic will be monitored on a daily basis and participants will be contacted if they are non-adherence 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
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

Eligibility Criteria

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

You may qualify if:

  • Patients with a recent University of Pennsylvania Health System hospital (UPHS) discharge of congestive heart failure (CHF) aged 18-80 who will receive follow-up in a UPHS outpatient clinic.

You may not qualify if:

  • Patients will be excluded if they will not or cannot give consent or have a markedly shortened life expectancy (listed for heart transplant,have a ventricular assist device, are inotrope dependent, metastatic cancer, or dementia)
  • end-stage renal disease (since they may not produce urine and be responsive to diuretics).
  • on dialysis
  • Heart failure 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

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (5)

  • Klaiman T, Iannotte LG, Josephs M, Russell LB, Norton L, Mehta S, Troxel A, Zhu J, Volpp K, Asch DA. Qualitative analysis of a remote monitoring intervention for managing heart failure. BMC Cardiovasc Disord. 2023 Sep 7;23(1):440. doi: 10.1186/s12872-023-03456-9.

    PMID: 37679712DERIVED

  • Klaiman T, Ianotte LG, Josephs M, Russell LB, Norton L, Mehta S, Troxel A, Zhu J, Volpp K, Asch D. Qualitative Analysis of a Remote Monitoring Intervention for Managing Heart Failure. Res Sq [Preprint]. 2023 Jan 20:rs.3.rs-2206783. doi: 10.21203/rs.3.rs-2206783/v1.

    PMID: 36712044DERIVED

  • Asch DA, Troxel AB, Goldberg LR, Tanna MS, Mehta SJ, Norton LA, Zhu J, Iannotte LG, Klaiman T, Lin Y, Russell LB, Volpp KG. Remote Monitoring and Behavioral Economics in Managing Heart Failure in Patients Discharged From the Hospital: A Randomized Clinical Trial. JAMA Intern Med. 2022 Jun 1;182(6):643-649. doi: 10.1001/jamainternmed.2022.1383.

    PMID: 35532915DERIVED

  • Russell LB, Norton LA, Pagnotti D, Sevinc C, Anderson S, Finnerty Bigelow D, Iannotte LG, Josephs M, McGilloway R, Barankay I, Putt ME, Reese PP, Asch DA, Goldberg LR, Mehta SJ, Tanna MS, Troxel AB, Volpp KG. Using Clinical Trial Data to Estimate the Costs of Behavioral Interventions for Potential Adopters: A Guide for Trialists. Med Decis Making. 2021 Jan;41(1):9-20. doi: 10.1177/0272989X20973160. Epub 2020 Nov 20.

    PMID: 33218296DERIVED

  • Mehta SJ, Volpp KG, Asch DA, Goldberg LR, Russell LB, Norton LA, Iannotte LG, Troxel AB. Rationale and Design of EMPOWER, a Pragmatic Randomized Trial of Automated Hovering in Patients With Congestive Heart Failure. Circ Cardiovasc Qual Outcomes. 2019 Apr;12(4):e005126. doi: 10.1161/CIRCOUTCOMES.118.005126.

    PMID: 30939922DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2016

First Posted

March 15, 2016

Study Start

May 22, 2016

Primary Completion

April 7, 2020

Study Completion

December 31, 2021

Last Updated

May 18, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will share

Only aggregate data will be shared, not on individual level

Locations

US(1)