Medication AdherenceNCT00985452
The Impact of GlowCaps Connect™ and Its Services on Hypertension Medication Adherence
A study testing GlowCaps Connect system and Glow cap system - deactivated in people with Medication Adherence, run by Massachusetts General Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Medication Adherence
- What is being tested?
- GlowCaps Connect system and Glow cap system - deactivated
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- No sites listed yet
- Study dates
- Aug 2009to Aug 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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.
- Conditions
- Medication Adherence
- Being tested
- GlowCaps Connect system, Glow cap system - deactivated
- Keywords
- Medication, Adherence, Hypertension
- Medical subject headings
- Medication Adherence, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlowCaps Connect systemOther
Also called Vitality GlowCaps Connect
The GlowCaps Connect system is an electronic medication reminder system, which provides reminders to help people to remember to take their medication.
Glow cap system - deactivatedOther
Also called Vitality GlowCaps
The Glow cap system - deactivated is an electronic medication system, which will track medication adherence.
| Study group | Role | What they receive |
|---|---|---|
| Group 2: Intervention | Other | Subjects in Group two will received an activated GlowCaps system, which will remind them to take their medication. Receives: 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. Receives: 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. Receives: Other: Glow cap system - deactivated |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantify the impact of GlowCaps Connect™ and its services on hypertension medication adherence
Measured: 6 months
Secondary outcomes (1)
Assess the usability and satisfaction of the GlowCap system
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2009 (estimated)
- Study startAug 2009
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medication AdherenceStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph C. Kvedar, Massachusetts General Hospital
- Investigators
- Joseph C Kvedar, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00985452
- Sponsor's protocol ID
- 2009-P-000254/3;MGH
- Status last verified
- Oct 2012
- First submitted
- 24 Sep 2009
- Last updated
- 10 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of GlowCaps Connect™ and Its Services on Hypertension Medication Adherence: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00985452
- Acronym / sponsor ID
- 2009-P-000254/3;MGH
- Conditions
- Medication Adherence
- Keywords
- Medication, Adherence, Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 28 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 2: Intervention | Other | Other: GlowCaps Connect systemSubjects in Group two will received an activated GlowCaps system, which will remind them to take their medication. |
| Group 3: Intervention/financial incentive | Other | Other: GlowCaps Connect systemSubjects 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 | Other | Other: Glow cap system - deactivatedSubjects in group one will receive a de-activated GlowCaps system, which will not provide the reminder service. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GlowCaps Connect systemAlso: Vitality GlowCaps ConnectThe GlowCaps Connect system is an electronic medication reminder system, which provides reminders to help people to remember to take their medication. | Other | Group 2: Intervention, Group 3: Intervention/financial incentive |
| Glow cap system - deactivatedAlso: Vitality GlowCapsThe Glow cap system - deactivated is an electronic medication system, which will track medication adherence. | Other | Group 1: Control |
Primary outcome
Quantify the impact of GlowCaps Connect™ and its services on hypertension medication adherence
Time frame: 6 months
1 secondary outcome
Assess the usability and satisfaction of the GlowCap system
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph C Kvedar, MD principal investigator
Massachusetts General Hospital
Questions about this trial
What is this clinical trial studying?
A study testing GlowCaps Connect system and Glow cap system - deactivated in people with Medication Adherence, run by Massachusetts General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantify the impact of GlowCaps Connect™ and its services on hypertension medication adherence (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2012.