The Impact of GlowCaps Connect™ and Its Services on Hypertension Medication Adherence

October 9, 2012 updated by: Joseph C. Kvedar, Massachusetts General Hospital

The Impact of GlowCaps Connect™ and Its Services on Hypertension Medication Adherence: A Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Participants will use the GlowCap system for 6 months.

Group 1

  • The GlowCap bottle provided for subjects in this group will passively track medication adherence over the course of the study
  • The pill cap will collect data, but will not provide any visual or auditory alerts
  • An Ethernet Gateway connector will collect adherence data from the pill bottle cap via a local wireless network. This data will be sent out of subject's home through the internet.

Group 2

  • Subjects in this group will be given daily visual, auditory, and phone call reminders to take their medication via the GlowCap system if they fail to take their hypertension medication at the scheduled dose time
  • An Ethernet Gateway connector will collect adherence data from the pill bottle cap via a local wireless network. This data will be sent out of subject's home through the internet.
  • Subjects will receive Weekly and Monthly Progress Reports by email and mail, respectively. Reports will include information about medication adherence and target goals. If a subject does not opt-out, Monthly Progress Reports will also be sent to the subject's primary care physician (PCP)
  • If the subject chooses, a friend or family member will receive a Weekly Progress Report by email
  • If the subject chooses, he/she will receive prompts (via automated telephone call twice a month) to refill his/her prescription
  • Subjects demonstrating consistent low adherence to medication will receive additional support in the form of calls from Vitality reminding them to take the medication.

Group 3

  • Subjects in this group will be given daily visual, auditory, and phone call reminders to take their medication via the GlowCap system if they fail to take their hypertension medication at the scheduled dose time
  • An Ethernet Gateway connector will collect adherence data from the pill bottle cap via a local wireless network. This data will be sent out of subject's home through the internet.
  • Subjects will receive Weekly and Monthly Progress Reports by email and mail, respectively. Reports will include information about medication adherence and target goals. If a subject does not opt-out, Monthly Progress Reports will also be sent to the subject's primary care physician (PCP)
  • If the subject chooses, a friend or family member will receive a Weekly Progress Report by email
  • Subjects will receive financial incentives in the form of a check for meeting a target adherence goal of 80% adherence over each month. The check will be mailed to them at the end of the study.
  • If the subjects chooses, he/she will receive prompts (via automated telephone call twice a month) to refill his/her prescription
  • Subjects demonstrating consistent low adherence to medication will receive additional support in the form of calls from Vitality reminding them to take the medication and may receive increased financial incentives to meet their target.

Study subjects will attend two study visits, one at the beginning and one at the end of the 6 month period. At these visits they will have their blood pressure recorded and will be asked to complete a survey.

Study Type

Interventional

Enrollment (Actual)

139

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Group 2: Intervention
Subjects in Group two will received an activated GlowCaps system, which will remind them to take their medication.
Other: GlowCaps Connect system
The GlowCaps Connect system is an electronic medication reminder system, which provides reminders to help people to remember to take their medication.
Other Names:
  • Vitality GlowCaps Connect
Other: Group 3: Intervention/financial incentive
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
The GlowCaps Connect system is an electronic medication reminder system, which provides reminders to help people to remember to take their medication.
Other Names:
  • Vitality GlowCaps Connect
Other: Group 1: Control
Subjects in group one will receive a de-activated GlowCaps system, which will not provide the reminder service.
Other: Glow cap system - deactivated
The Glow cap system - deactivated is an electronic medication system, which will track medication adherence.
Other Names:
  • Vitality GlowCaps

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Quantify the impact of GlowCaps Connect™ and its services on hypertension medication adherence
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Assess the usability and satisfaction of the GlowCap system
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Investigators

  • Principal Investigator: Joseph C Kvedar, MD, Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

September 24, 2009

First Submitted That Met QC Criteria

September 25, 2009

First Posted (Estimate)

September 28, 2009

Study Record Updates

Last Update Posted (Estimate)

October 10, 2012

Last Update Submitted That Met QC Criteria

October 9, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009-P-000254/3;MGH

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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