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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
139

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Massachusetts General Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 24, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 25, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 28, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 10, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 9, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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