The Impact of GlowCaps Connect™ and Its Services on Hypertension Medication Adherence
1 other identifier
interventional
139
0 countries
N/A
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2009
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
Study Start
First participant enrolled
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 24, 2009
CompletedFirst Posted
Study publicly available on registry
September 28, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedOctober 10, 2012
October 1, 2012
1 year
September 24, 2009
October 9, 2012
Conditions
Keywords
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
OTHERSubjects in Group two will received an activated GlowCaps system, which will remind them to take their medication.
Group 3: Intervention/financial incentive
OTHERSubjects 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.
Group 1: Control
OTHERSubjects in group one will receive a de-activated GlowCaps system, which will not provide the reminder service.
Interventions
The GlowCaps Connect system is an electronic medication reminder system, which provides reminders to help people to remember to take their medication.
The Glow cap system - deactivated is an electronic medication system, which will track medication adherence.
Eligibility Criteria
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
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joseph C Kvedar, MD
Massachusetts General Hospital
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