NCT02148523

Brief Summary

To assess the effectiveness of social comparison in improving the outcome of statin adherence versus usual care as measured by an electronic pill bottle. Subjects receiving weekly reports with their adherence and information about their place in the distribution of their peers will have the highest statin adherence of any arm, as measured by electronic pill bottle.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
201

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2014

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

December 17, 2013

Completed
15 days until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
5 months until next milestone

First Posted

Study publicly available on registry

May 28, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

May 23, 2017

Completed
Last Updated

July 13, 2017

Status Verified

July 1, 2017

Enrollment Period

9 months

First QC Date

December 17, 2013

Results QC Date

April 14, 2017

Last Update Submit

July 11, 2017

Conditions

Medication AdherenceHigh Blood PressureDiabetes

Keywords

Medication AdherenceHigh Blood PressureDiabetesStatins

Outcome Measures

Primary Outcomes (1)

  • Statin Adherence

    The primary outcome will be the percent of statin doses taken during the study as measured by the GlowCaps.

    90 days

Secondary Outcomes (1)

  • Morisky Medication Adherence Scale (MMAS)

    90 days

Study Arms (3)

Weekly Adherence Report

EXPERIMENTAL

Adherence report to subject every 7 days.

Behavioral: Adherence feedbackDevice: Electronic pill bottle

Weekly Adherence Peer-Comparison Report

EXPERIMENTAL

Adherence report to subject every 7 days with tailored comparison messages based on subject's adherence.

Behavioral: Comparison to peersDevice: Electronic pill bottle

Usual Care

OTHER

Usual care with GlowCap.

Device: Electronic pill bottle

Interventions

Comparison to peersBEHAVIORAL
Weekly Adherence Peer-Comparison Report
Adherence feedbackBEHAVIORAL
Weekly Adherence Report
Electronic pill bottleDEVICE

This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial.

Also known as: Vitality GlowCap
Usual CareWeekly Adherence Peer-Comparison ReportWeekly Adherence Report

Eligibility Criteria

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

You may qualify if:

  • The subject is Humana insured
  • The subject is an English speaking adult
  • Age range ≥18 years
  • The subject has diagnosis with diabetes for ≥12 months
  • The subject has an MPR \<70% to a statin medication
  • Subjects denies side-effects to their statin medication

You may not qualify if:

  • The subject is \<18 years old
  • The subject is considered part of a vulnerable population (is a prisoner, a cognitively impaired person, or a pregnant woman)
  • On statin combination medication
  • The subject does not identify an individual who agrees to serve as their MAP
  • The subject reports a clinically important side effect to the statin medication or active liver disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Medication AdherenceHypertensionDiabetes Mellitus

Condition Hierarchy (Ancestors)

Patient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorVascular DiseasesCardiovascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Limitations and Caveats

The interventions lasted only 3 months; differences in adherence might emerge over a longer period of time. The primary outcome of pill-bottle-measured adherence has limitations, including bottle malfunction.

Results Point of Contact

Title
Dr. Peter P. Reese
Organization
University of Pennsylvania
peter.reese@uphs.upenn.edu
215-898-6086

Study Officials

  • Peter P Reese, MD, MSCE

    UPenn, PSOM

    PRINCIPAL INVESTIGATOR

  • Judd B Kessler, PhD

    UPenn, Wharton

    PRINCIPAL INVESTIGATOR

  • Kevin Volpp, MD, PhD

    UPenn, PSOM

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

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

Study Record Dates

First Submitted

December 17, 2013

First Posted

May 28, 2014

Study Start

January 1, 2014

Primary Completion

October 1, 2014

Study Completion

January 1, 2015

Last Updated

July 13, 2017

Results First Posted

May 23, 2017

Record last verified: 2017-07

Locations

US(1)