NCT00985452

Brief Summary

The investigators hypothesize that providing subjects on a once-a-day hypertension medication with GlowCaps ConnectTM will lead to an improvement in their medication adherence. The investigators propose to conduct a 6-month randomized control trial to assess the effect of the GlowCaps Connect™ system on the enhancement of hypertension medication adherence among subjects with a diagnosis of hypertension recruited from the greater Boston area. 130 subjects will be enrolled. Subjects will be randomized into either the control group or into one of two intervention groups.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
139

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2009

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

August 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 24, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 28, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

October 10, 2012

Status Verified

October 1, 2012

Enrollment Period

1 year

First QC Date

September 24, 2009

Last Update Submit

October 9, 2012

Conditions

Keywords

MedicationAdherenceHypertension

Outcome Measures

Primary Outcomes (1)

  • Quantify the impact of GlowCaps Connect™ and its services on hypertension medication adherence

    6 months

Secondary Outcomes (1)

  • Assess the usability and satisfaction of the GlowCap system

    6 months

Study Arms (3)

Group 2: Intervention

OTHER

Subjects in Group two will received an activated GlowCaps system, which will remind them to take their medication.

Other: GlowCaps Connect system

Group 3: Intervention/financial incentive

OTHER

Subjects in group 3 will receive an activated GlowCaps system, which will provide them with reminders to take their medication, Subjects in group 3 will also receive an additional financial incentive, the amount will be based on how often they remembered to take their medication during the 6-month study.

Other: GlowCaps Connect system

Group 1: Control

OTHER

Subjects in group one will receive a de-activated GlowCaps system, which will not provide the reminder service.

Other: Glow cap system - deactivated

Interventions

The GlowCaps Connect system is an electronic medication reminder system, which provides reminders to help people to remember to take their medication.

Also known as: Vitality GlowCaps Connect
Group 2: InterventionGroup 3: Intervention/financial incentive

The Glow cap system - deactivated is an electronic medication system, which will track medication adherence.

Also known as: Vitality GlowCaps
Group 1: Control

Eligibility Criteria

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

You may qualify if:

  • Adult men and women age 18 and over
  • Diagnosis of hypertension
  • Take a once a day medication for hypertension
  • Internet access via broadband (not dial-up)
  • Home router
  • A private email account
  • Fluency in English (spoken and written)
  • Have a Primary Care Physician

You may not qualify if:

  • People will be excluded if they are not able to adequately respond to researcher's questions or complete the surveys.
  • People with significant cognitive deficits will be excluded.
  • People will be excluded if they take more than three medications a day for hypertension.
  • People will be excluded if they take more than five medications in one day.
  • People will be excluded if they have total color blindness.
  • People will be excluded if they are both blind and deaf.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Medication AdherenceHypertension

Condition Hierarchy (Ancestors)

Patient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorVascular DiseasesCardiovascular Diseases

Study Officials

  • Joseph C Kvedar, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Center for Connected Health

Study Record Dates

First Submitted

September 24, 2009

First Posted

September 28, 2009

Study Start

August 1, 2009

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

October 10, 2012

Record last verified: 2012-10