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Heart FailureEMPOWERNCT02708654

Automated Hovering for Congestive Heart Failure Patients

A study testing Electronic pill bottle, Bluetooth scale and Support Partner in people with Heart Failure, run by University of Pennsylvania at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Heart Failure
What is being tested?
Electronic pill bottle, Bluetooth scale and Support Partner
Could I receive a placebo?
No, everyone receives an active treatment
How many people
566 participants
Where
1 siteUnited States
Study dates
22 May 2016to 31 Dec 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: Automated Hovering for Congestive Heart Failure Management: (EMPOWER) Electronic Monitoring of Patients Offers Way to Enhance Rehabilitation

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.

Read the detailed description

Using a 2-arm, randomized, controlled trial (RCT) among congestive heart failure (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. This will leverage the electronic medical record (EMR), the Penn Data Store (an electronic repository that can be used to identify study cohorts), and the NIH-funded Way to Health platform, which provides linkages between home-based remote monitoring devices and a server that can provide automated feedback to patients. The primary outcome will be hospital readmission rate during the 12 months of study enrollment. Secondary outcomes will include cost, medication adherence and death. The investigators will enroll CHF patients discharged from UPHS and randomize them to either: usual care with no additional intervention; or 1) the provision of wireless pill bottles and scales with daily lottery incentives to encourage daily adherence 2) asked to provide the name and contact information of a family member or friend to serve as their support partner 3) have their weights monitored for clinically significant threshold, with verified weight gains alerts sent to the managing physician through the EMR. Managing providers will also be sent a weekly report of all weight measurements from the electronic scale.

Conditions
Heart Failure
Being tested
Electronic pill bottle, Bluetooth scale, Support Partner, Engagement incentives
Keywords
Remote monitoring, Incentives
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Electronic pill bottleBehavioural

    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

  • Bluetooth scaleBehavioural

    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.

  • Support PartnerBehavioural

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

  • Engagement incentivesBehavioural

    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.

Study groups in NCT02708654
Study groupRoleWhat they receive
InterventionExperimentalParticipants 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
Receives: Behavioral: Electronic pill bottle; Behavioral: Bluetooth scale; Behavioral: Support Partner; Behavioral: Engagement incentives
ControlNo interventionParticipants will receive usual care.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 months

Secondary outcomes (3)

  1. Cost

    To assess the cost-effectiveness of the intervention, the investigators will use analytic methods for economic evaluations in clinical trials.

    Measured: 12 months

  2. Medication adherence to diuretic as measured by electronic pill bottle

    Days adherent to medication adherence to diuretic, as measured by electronic pill bottle

    Measured: 12 months

  3. Deaths

    Deaths

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Mar 2016 (estimated)
  2. Study start22 May 2016
  3. Primary completion7 Apr 2020
  4. Study completion31 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
566 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02708654
Sponsor's protocol ID
824816
Other IDs
1R01HL128465-01
Acronym
EMPOWER
Status last verified
May 2022
First submitted
10 Mar 2016
Last updated
18 May 2022
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes: Only aggregate data will be shared, not on individual level

Publications

  • 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.

    PubMed 37679712

  • 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.

    PubMed 36712044

  • 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.

    PubMed 35532915

  • 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.

    PubMed 33218296

  • 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.

    PubMed 30939922

Questions about this trial

What is this clinical trial studying?

A study testing Electronic pill bottle, Bluetooth scale and Support Partner in people with Heart Failure, run by University of Pennsylvania at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hospital readmission rate (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02708654, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2022.

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