NCT02778542

Brief Summary

The goal of this pilot study is to test different approaches to monitor medication adherence in hypertension patients, leveraging the NIH-funded Way to Health platform. Patients with poor blood pressure control will be recruited from the University of Pennsylvania Health System practices and offered remote monitoring with electronic pill bottles, bidirectional text messaging or usual care. Our aim is to analyze and compare the effects of remote monitoring with electronic pill bottles versus bidirectional messaging on blood pressure reduction after 4 months.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
Completed

Started May 2016

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

Study Start

First participant enrolled

May 1, 2016

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

May 12, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 20, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 7, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 7, 2017

Completed
Last Updated

October 4, 2019

Status Verified

October 1, 2019

Enrollment Period

1.1 years

First QC Date

May 12, 2016

Last Update Submit

October 1, 2019

Conditions

Hypertension

Keywords

Automated HoveringRemote MonitoringBidirectional Text Messaging

Outcome Measures

Primary Outcomes (1)

  • Systolic blood pressure

    The primary outcome will be the systolic blood pressure during the 4 month in-person visit, controlling for the initial systolic blood pressure

    after 4 month intervention

Secondary Outcomes (2)

  • Medication Adherence

    4 month intervention

  • Passive EMR monitoring

    12 months, including 4 months of intervention and 8 months after intervention

Study Arms (3)

Electronic Pill Bottle

ACTIVE COMPARATOR

Participants will be mailed an electronic pill bottle for their blood pressure medication.These pill bottles will track how often the participant opens the bottle to take their medication and will transmit that information to study team via cellular data. Participants will also receive a daily text message reminder to take your blood pressure medication.

Behavioral: Electronic Pill Bottle

Bidirectional Text Messaging

ACTIVE COMPARATOR

Participants assigned to bi-directional texting, will receive a daily text message reminder to take their blood pressure medication. Patients in this arm are expected to send a response to the reminder message, indicating if they took their medication that day.

Behavioral: Bidirectional Text Messaging

Usual Care

NO INTERVENTION

Participants in this arm do not receive a medication reminder system.

Interventions

Electronic Pill BottleBEHAVIORAL

Patients receive electronic pill bottle for their blood pressure medication. Study team can monitor pill bottle openings. Patients also receive daily text reminders to take their blood pressure medication.

Electronic Pill Bottle
Bidirectional Text MessagingBEHAVIORAL

Patients receive daily text reminders to take their blood pressure medication. Patients are asked to text their adherence daily.

Bidirectional Text Messaging

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hypertension patients aged 18-75
  • At least two clinic visits in the past 12 months
  • Blood pressure readings in the last two visits that exceed recommended guidelines (150/90 or 140/90 if aged 21-59 yrs. or with diabetes or nondiabetic CKD).
  • Cellular phone with text messaging capabilities
  • Prescribed at least one medication for hypertension

You may not qualify if:

  • Will not or cannot give consent
  • Diagnosed with dementia, end stage renal disease, cirrhosis, or metastatic cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Mehta SJ, Volpp KG, Troxel AB, Day SC, Lim R, Marcus N, Norton L, Anderson S, Asch DA. Electronic Pill Bottles or Bidirectional Text Messaging to Improve Hypertension Medication Adherence (Way 2 Text): a Randomized Clinical Trial. J Gen Intern Med. 2019 Nov;34(11):2397-2404. doi: 10.1007/s11606-019-05241-x. Epub 2019 Aug 8.

    PMID: 31396815DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Shivan Mehta, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2016

First Posted

May 20, 2016

Study Start

May 1, 2016

Primary Completion

June 7, 2017

Study Completion

November 7, 2017

Last Updated

October 4, 2019

Record last verified: 2019-10