HypertensionNCT00277381
Improving Adherence in Patients With Hypertension - A Novel Use of Communication Technology
A study testing Automated feedback regarding drug adherence in people with Hypertension, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Treating hypertension is known to decrease morbidity and mortality. Despite this 70% of patients do not have adequately controlled blood pressure. The main reason for this is non-adherence to recommended drug therapy. Although strategies have been developed to improve adherence many are time consuming and expensive. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Automated feedback regarding drug adherence
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to Jan 2008
- 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 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Prescription of a once-a-day dose of atenolol.
- Morisky Score of less than or equal to 2 (explanation in 'Equitable Selection of Subjects').
- Fluency in English.
- Age 45-65 inclusive.
- Primary Care Physician consent to the patient taking part.
Who cannot join
- Patients prescribed more than two anti-hypertensive agents.
- Patients prescribed more than four medications in total.
- Patients on secondary prevention following cardiac event or stroke.
- Morisky Score of more than 2.
- Patients with visual impairment or color-blindness.
- Patients with congenital or acquired cognitive impairment.
- Patients with a cardiac pacemaker
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Treating hypertension is known to decrease morbidity and mortality. Despite this 70% of patients do not have adequately controlled blood pressure. The main reason for this is non-adherence to recommended drug therapy. Although strategies have been developed to improve adherence many are time consuming and expensive. We propose to use communications technology to develop a novel means of improving adherence to antihypertensive therapy. We will conduct a randomised, single-blinded, controlled study to assess the impact of a real-time, automated reminder system on adherence rates. This will involve adapting two pieces of currently available technology - the electronic pill bottle and the Ambient Globe. The Globe will change colour in response to information received, via a wireless link, from the patient's electronic pill bottle. We hypothesise that this will provide patients with an up to date, but unobtrusive, reminder of their adherence status and thus effect positive behavioural change. We will measure the impact of this intervention on adherence rates as well as assessing patient views and the impact on provider workload. This trial will elucidate the role of communications technology in improving adherence behaviour and allow us to develop further strategies to tackle this major health issue.
- Conditions
- Hypertension
- Being tested
- Automated feedback regarding drug adherence
- Keywords
- Adherence, Hypertension, Telemedicine
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated feedback regarding drug adherenceBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence rates as measured using data held in the SIMpill database
Patient satisfaction with intervention as assessed by questionnaire at the end of the study.
Technical difficulties as assessed by interview at the end of the study and by review of the technical log.
Secondary outcomes (4)
Discontinuation rates of medication as assessed at the end of trial debrief.
Changes to medication regime as assessed at the end of trial debrief.
Adverse events (e.g. hospitalisation) as assessed from the log of withdrawals from the trial.
Blood pressure as measured on enrollment and at end of trial debrief.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2006 (estimated)
- Study startJul 2006
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies 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
- Single group
- Masking
- Single blind
- Enrolment
- 84 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, Partners Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00277381
- Sponsor's protocol ID
- 2005-P-002248
- Status last verified
- Feb 2013
- First submitted
- 13 Jan 2006
- Last updated
- 1 Mar 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Adherence in Patients With Hypertension - A Novel Use of Communication Technology
- ClinicalTrials.gov ID
- NCT00277381
- Acronym / sponsor ID
- 2005-P-002248
- Conditions
- Hypertension
- Keywords
- Adherence, Hypertension, Telemedicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Jul 2006
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 16 Jan 2006 (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.
Treating hypertension is known to decrease morbidity and mortality. Despite this 70% of patients do not have adequately controlled blood pressure. The main reason for this is non-adherence to recommended drug therapy. Although strategies have been developed to improve adherence many are time consuming and expensive. We propose to use communications technology to develop a novel means of improving adherence to antihypertensive therapy. We will conduct a randomised, single-blinded, controlled study to assess the impact of a real-time, automated reminder system on adherence rates. This will involve adapting two pieces of currently available technology - the electronic pill bottle and the Ambient Globe. The Globe will change colour in response to information received, via a wireless link, from the patient's electronic pill bottle. We hypothesise that this will provide patients with an up to date, but unobtrusive, reminder of their adherence status and thus effect positive behavioural change. We will measure the impact of this intervention on adherence rates as well as assessing patient views and the impact on provider workload. This trial will elucidate the role of communications technology in improving adherence behaviour and allow us to develop further strategies to tackle this major health issue.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Prescription of a once-a-day dose of atenolol.
- Morisky Score of less than or equal to 2 (explanation in 'Equitable Selection of Subjects').
- Fluency in English.
- Age 45-65 inclusive.
- Primary Care Physician consent to the patient taking part.
Key exclusion criteria (7 listed)
- Patients prescribed more than two anti-hypertensive agents.
- Patients prescribed more than four medications in total.
- Patients on secondary prevention following cardiac event or stroke.
- Morisky Score of more than 2.
- Patients with visual impairment or 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 |
|---|---|---|
| Automated feedback regarding drug adherence | Behavioural | – |
Primary outcome
Adherence rates as measured using data held in the SIMpill database
Patient satisfaction with intervention as assessed by questionnaire at the end of the study.
Technical difficulties as assessed by interview at the end of the study and by review of the technical log.
4 secondary outcomes
Discontinuation rates of medication as assessed at the end of trial debrief.
Changes to medication regime as assessed at the end of trial debrief.
Adverse events (e.g. hospitalisation) as assessed from the log of withdrawals from the trial.
Blood pressure as measured on enrollment and at end of trial debrief.
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 1 Mar 2013.
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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
Partners Healthcare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Automated feedback regarding drug adherence in people with Hypertension, run by Massachusetts General Hospital at 1 site in United States.
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 5 inclusion and 7 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 1 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Adherence rates as measured using data held in the SIMpill database. The study lists 3 primary outcomes in all. 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 1 Mar 2013.