NCT03753568

Brief Summary

In this study, the effect of an electronic device attached to a push through pill package and a smart phone application on chronic disease medication adherence is studied.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 21, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 27, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

March 20, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

March 25, 2019

Status Verified

March 1, 2019

Enrollment Period

4 months

First QC Date

November 21, 2018

Last Update Submit

March 21, 2019

Conditions

Anticoagulant DrugsDiabetes Mellitus, Type 2

Keywords

medicine reminderdiabetes mellitus, type 2direct oral anticoagulants

Outcome Measures

Primary Outcomes (1)

  • Adherence to the medication

    PDC - proportion of days covered

    8 months

Secondary Outcomes (1)

  • Variation of daily pill taking times

    8 months

Study Arms (1)

Study group

EXPERIMENTAL

The participants use either direct oral anticoagulants or oral diabetic medication.

Device: Electronic medicine reminder system

Interventions

Electronic medicine reminder systemDEVICE

Electronic surveillance device is attached to the participants push through pill sheet and the smart phone application reminds the participants to take their medicine if they are about to take their daily dosage.

Study group

Eligibility Criteria

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

You may qualify if:

  • use of direct oral anticoagulants or oral diabetic drugs
  • age of 18 or more
  • subjects have been using a smart phone

You may not qualify if:

  • patients who don't use their medication without help

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helsinki University Hospital

Helsinki, 00029, Finland

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Subjects are monitored first before the intervention and then during the intervention.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief medical officer, Popit Ltd

Study Record Dates

First Submitted

November 21, 2018

First Posted

November 27, 2018

Study Start

March 20, 2019

Primary Completion

July 30, 2019

Study Completion

September 1, 2019

Last Updated

March 25, 2019

Record last verified: 2019-03

Locations

FI(1)