Medication AdherencePRIMANCT02060981
Evaluation of a Decision Support Tool
A study testing Interview Only and Interview plus decision support tool in people with Medication Adherence and Hypertension, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
Investigators will conduct a randomized trial with patients, through one-on-one interviews, to evaluate their understanding of and willingness to use a decision support tool and to determine if receiving and discussing the decision support tool improves the likelihood that a patient is adherent to a new… Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Medication Adherence, Hypertension, Decision Making, Shared
- What is being tested?
- Interview Only and Interview plus decision support tool
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Apr 2015
- 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 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- does not pick up a prescription for a new antihypertensive medication within 14 days as identified by CVS pharmacy, their retail pharmacy provider.
- High blood pressure diagnosis
Who cannot join
- under age 25.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Primary Medication Adherence Phase 2 Evaluation of a Decision Support Tool
Investigators will conduct a randomized trial with patients, through one-on-one interviews, to evaluate their understanding of and willingness to use a decision support tool and to determine if receiving and discussing the decision support tool improves the likelihood that a patient is adherent to a new antihypertensive medication.
- Conditions
- Medication Adherence, Hypertension, Decision Making, Shared, Patient-Centered Outcomes Research
- Being tested
- Control, Interview Only, Interview plus decision support tool
- Keywords
- Randomized controlled trial, Primary medication adherence, Decision-support tool, Patient-centered outcomes research, Antihypertensive medications, One-on-one patient interviews
- 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.
ControlBehavioural
Control group patients will then be mailed an American Heart Association brochure regarding hypertension and a brief, 5-question, paper-based survey.
Interview OnlyBehavioural
Patients will be asked to participate in an interview regarding their views on hypertension and taking medications to treat hypertension.
Interview plus decision support toolBehavioural
Patients will be asked to participate in an interview regarding their views on hypertension and taking medications to treat hypertension and to provide feedback regarding a new decision support tool for helping patients learn more about their medications.
| Study group | Role | What they receive |
|---|---|---|
| Interview only | Active comparator | Patients will be asked to participate in an interview regarding their views on hypertension and taking medications to treat hypertension. Receives: Behavioral: Interview Only |
| Control | Placebo comparator | Control group patients will then be mailed an American Heart Association brochure regarding hypertension and a brief, 5-question, paper-based survey. These patients will be asked to review the brochure, complete the survey, and mail it back to the research team using a self-addressed stamped envelope. Receives: Behavioral: Control |
| Interview plus decision support tool | Experimental | Patients will be asked to participate in an interview regarding their views on hypertension and taking medications to treat hypertension, and to provide feedback regarding a new tool for helping patients learn more about their medications. Interview plus patients' index date for follow-up is the date of the scheduled interview. Receives: Behavioral: Interview plus decision support tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative incidence of antihypertensive medication fills
The proportion of patients in each group who picked up a prescription for an antihypertensive medication in any class during the follow-up period. Investigators will calculate cumulative incidences among all patients, whether or not they successfully completed the interview or returned the paper-based survey (Intention to Treat) and among only those patients who did complete the interview or returned the paper-based survey (As Treated).
Measured: 6 months
Secondary outcomes (1)
Patient Interviews
One-on-one structured interviews will ask about participants' preferences, attitudes and beliefs regarding primary adherence and/or use of a decision support tool.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionMar 2015 (estimated)
- Study completionApr 2015 (estimated)
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 Brigham and Women's 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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Foundation for Informed Medical Decision Making
- Responsible party
- Principal investigator, Jennifer Polinski, Brigham and Women's Hospital
- Investigators
- Jennifer Polinski, Sc.D., Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02060981
- Sponsor's protocol ID
- 2014-P-00008959
- Other IDs
- #2013P001295/BWH
- Acronym
- PRIMA
- Status last verified
- Feb 2015
- First submitted
- 10 Feb 2014
- Last updated
- 18 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Medication Adherence Phase 2 Evaluation of a Decision Support Tool
- ClinicalTrials.gov ID
- NCT02060981
- Acronym / sponsor ID
- PRIMA / 2014-P-00008959
- Conditions
- Medication Adherence, Hypertension, Decision Making, Shared, Patient-Centered Outcomes Research
- Keywords
- Randomized controlled trial, Primary medication adherence, Decision-support tool, Patient-centered outcomes research, Antihypertensive medications, One-on-one patient interviews
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Foundation for Informed Medical Decision Making
- Study start
- Feb 2014
- Primary completion
- Mar 2015 (estimated)
- Study completion
- Apr 2015 (estimated)
- First posted
- 12 Feb 2014 (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.
Investigators will conduct a randomized trial with patients, through one-on-one interviews, to evaluate their understanding of and willingness to use a decision support tool and to determine if receiving and discussing the decision support tool improves the likelihood that a patient is adherent to a new antihypertensive medication.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Interview only | Active comparator | Behavioral: Interview OnlyPatients will be asked to participate in an interview regarding their views on hypertension and taking medications to treat hypertension. |
| Control | Placebo comparator | Behavioral: ControlControl group patients will then be mailed an American Heart Association brochure regarding hypertension and a brief, 5-question, paper-based survey. These patients will be asked to review the brochure, complete the survey, and mail it back to the research team using a self-addressed stamped envelope. |
| Interview plus decision support tool | Experimental | Behavioral: Interview plus decision support toolPatients will be asked to participate in an interview regarding their views on hypertension and taking medications to treat hypertension, and to provide feedback regarding a new tool for helping patients learn more about their medications. Interview plus patients' index date for follow-up is the date of the scheduled interview. |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- does not pick up a prescription for a new antihypertensive medication within 14 days as identified by CVS pharmacy, their retail pharmacy provider.
- High blood pressure diagnosis
Key exclusion criteria (1 listed)
- under age 25.
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 |
|---|---|---|
| ControlControl group patients will then be mailed an American Heart Association brochure regarding hypertension and a brief, 5-question, paper-based survey. | Behavioural | Control |
| Interview OnlyPatients will be asked to participate in an interview regarding their views on hypertension and taking medications to treat hypertension. | Behavioural | Interview only |
| Interview plus decision support toolPatients will be asked to participate in an interview regarding their views on hypertension and taking medications to treat hypertension and to provide feedback regarding a new decision support tool for helping patients learn more about their medications. | Behavioural | Interview plus decision support tool |
Primary outcome
Cumulative incidence of antihypertensive medication fills
Time frame: 6 months
The proportion of patients in each group who picked up a prescription for an antihypertensive medication in any class during the follow-up period. Investigators will calculate cumulative incidences among all patients, whether or not they successfully completed the interview or returned the paper-based survey (Intention to Treat) and among only those patients who did complete the interview or returned the paper-based survey (As Treated).
1 secondary outcome
Patient Interviews
Time frame: 5 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2015.
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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.
Jennifer Polinski, Sc.D. principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interview Only and Interview plus decision support tool in people with Medication Adherence and Hypertension, run by Brigham and Women's 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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 18 Feb 2015. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
Cumulative incidence of antihypertensive medication fills (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 18 Feb 2015.