NCT02411006

Brief Summary

The investigators seek to increase medication adherence of subjects. The investigators will send mailings to customers of an insurance company, asking them to predict or commit to a certain level of behavior. The investigators will measure whether this increases medication adherence.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
47,088

participants targeted

Target at P75+ for not_applicable diabetes

Timeline
Completed

Started Nov 2014

Shorter than P25 for not_applicable diabetes

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

Study Start

First participant enrolled

November 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 3, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 8, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

September 27, 2016

Status Verified

September 1, 2016

Enrollment Period

7 months

First QC Date

April 3, 2015

Last Update Submit

September 26, 2016

Conditions

DiabetesHypertension

Outcome Measures

Primary Outcomes (1)

  • Medication refills

    frequency of refilling medication

    6 months

Secondary Outcomes (2)

  • Hemoglobin A1C

    6 months

  • LDL cholesterol

    6 months

Study Arms (6)

Usual care control

NO INTERVENTION

No intervention, just usual care from the insurance company

Reminder control

EXPERIMENTAL

Send a reminder to subjects every month

Behavioral: Reminder

Anonymous prediction

EXPERIMENTAL

Ask subjects to anonymously predict their upcoming medication adherence

Behavioral: Prediction mailingBehavioral: ReminderBehavioral: Anonymity

Anonymous commitment

EXPERIMENTAL

Ask subjects to anonymously commit to their upcoming medication adherence

Behavioral: Commitment mailingBehavioral: ReminderBehavioral: Anonymity

Identified prediction

EXPERIMENTAL

Ask subjects to predict their upcoming medication adherence and report it

Behavioral: Prediction mailingBehavioral: ReminderBehavioral: Identification

Identified commitment

EXPERIMENTAL

Ask subjects to commit to their upcoming medication adherence and report it

Behavioral: Commitment mailingBehavioral: ReminderBehavioral: Identification

Interventions

Prediction mailingBEHAVIORAL

Ask people to predict their upcoming medication adherence

Anonymous predictionIdentified prediction
Commitment mailingBEHAVIORAL

Ask people to commit to their upcoming medication adherence

Anonymous commitmentIdentified commitment
ReminderBEHAVIORAL

Remind people to take their medicine

Anonymous commitmentAnonymous predictionIdentified commitmentIdentified predictionReminder control
AnonymityBEHAVIORAL

Keep patient predictions and commitment anonymous

Anonymous commitmentAnonymous prediction
IdentificationBEHAVIORAL

Ask patients to report their predictions and commitments

Identified commitmentIdentified prediction

Eligibility Criteria

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

You may qualify if:

  • customers of the investigators' insurance company partner

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • Dai H, Mao D, Volpp KG, Pearce HE, Relish MJ, Lawnicki VF, Milkman KL. The effect of interactive reminders on medication adherence: A randomized trial. Prev Med. 2017 Oct;103:98-102. doi: 10.1016/j.ypmed.2017.07.019. Epub 2017 Jul 24.

    PMID: 28751176DERIVED

MeSH Terms

Conditions

Diabetes MellitusHypertension

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Katherine Milkman, Ph.D

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2015

First Posted

April 8, 2015

Study Start

November 1, 2014

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

September 27, 2016

Record last verified: 2016-09

Locations

US(1)