High Blood PressureNCT03599050
Training in the 21st Century: Using Virtual Role-Plays to Improve Nurse Communication for Medication Adherence
A study testing Audiotaped Counseling Session in people with High Blood Pressure and Hypertension, run by NYU Langone Health at 1 site in United States.
Trial summary
This study will utilize a three-phase approach that is informed by a theory-driven implementation framework to: 1) conduct a needs analysis in order to identify individual-, health care team-, and practice-level barriers and facilitators to conducting adherence counseling in safety-net primary care practices; 2)… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- High Blood Pressure, Hypertension
- What is being tested?
- Audiotaped Counseling Session
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2018to 31 May 2020
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PCPs and nurses will be enrolled if they fulfill the following criteria:
- male or female healthcare provider (MD/DO, NP, and Registered Nurse) practicing at the clinic
- age 18 years or older.
- No exclusions will be made based on provider race/ethnic origin. We will oversample males to examine differential communication skills based on gender.
- Patient eligibility criteria include:
- receiving care at the participating clinic
Show all 10Show fewer
- having uncontrolled HTN (BP>140/90 mmHg) at two visits in the past year
- being prescribed at least one antihypertensive medication and are non-adherent
- are ≥age 18 years
- fluent in English
Who cannot join
- Unable to give consent
- Have a diagnosis of cognitive dysfunction or significant psychiatric comorbidity,
- Participating in another HTN-related study.
Trial locations and contacts
1 site in 1 country.
About this study
This study will utilize a three-phase approach that is informed by a theory-driven implementation framework to: 1) conduct a needs analysis in order to identify individual-, health care team-, and practice-level barriers and facilitators to conducting adherence counseling in safety-net primary care practices; 2) develop a virtual communication simulation designed to improve the quality of adherence counseling by allowing nurses repeated opportunities to practice discussing medication adherence with virtual patients; and 3) conduct a pilot study to evaluate the feasibility, acceptability and preliminary efficacy of the simulation on changes in: a) nurses' collaborative communication skills, b) medication adherence, and c) reduction in BP in a sample of 20 patients with uncontrolled hypertension (HTN) who are non-adherent to their medications.
- Conditions
- High Blood Pressure, Hypertension
- Being tested
- Audiotaped Counseling Session
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Audiotaped Counseling SessionBehavioural
Patients and nurses will complete audio taped counseling session at least 3 months following the baseline visit. Patients will rate quality of nurse communication skills
| Study group | Role | What they receive |
|---|---|---|
| Communication Simulation | Experimental | Nurses will use simulation over 12 weeks while fidelity is monitored using the NIH Behavior Change Consortium Treatment Fidelity Guidelines. Receives: Behavioral: Audiotaped Counseling Session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility measured by documenting total available and eligible nurses and patients approached to enroll 1 participant through final study visit
Measured: 6 Months
Acceptability measured by % of nurses who complete the simulation
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 posted26 Jul 2018
- Study start1 Dec 2018
- Primary completion4 May 2020
- Study completion31 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Blood PressureStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antoinette Schoenthaler, MD, Study director, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03599050
- Sponsor's protocol ID
- 18-01003
- Status last verified
- Jan 2022
- First submitted
- 17 Jul 2018
- Last updated
- 14 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices). Will be used for secondary data analysis approved by the investigator
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Training in the 21st Century: Using Virtual Role-Plays to Improve Nurse Communication for Medication Adherence
- ClinicalTrials.gov ID
- NCT03599050
- Acronym / sponsor ID
- 18-01003
- Conditions
- High Blood Pressure, Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 4 May 2020 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 26 Jul 2018 (actual)
- 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.
This study will utilize a three-phase approach that is informed by a theory-driven implementation framework to: 1) conduct a needs analysis in order to identify individual-, health care team-, and practice-level barriers and facilitators to conducting adherence counseling in safety-net primary care practices; 2) develop a virtual communication simulation designed to improve the quality of adherence counseling by allowing nurses repeated opportunities to practice discussing medication adherence with virtual patients; and 3) conduct a pilot study to evaluate the feasibility, acceptability and preliminary efficacy of the simulation on changes in: a) nurses' collaborative communication skills, b) medication adherence, and c) reduction in BP in a sample of 20 patients with uncontrolled hypertension (HTN) who are non-adherent to their medications.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Communication Simulation | Experimental | Behavioral: Audiotaped Counseling SessionNurses will use simulation over 12 weeks while fidelity is monitored using the NIH Behavior Change Consortium Treatment Fidelity Guidelines. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- PCPs and nurses will be enrolled if they fulfill the following criteria:
- No exclusions will be made based on provider race/ethnic origin. We will oversample males to examine differential communication skills based on gender.
- Patient eligibility criteria include:
Key exclusion criteria (3 listed)
- Unable to give consent
- Have a diagnosis of cognitive dysfunction or significant psychiatric comorbidity,
- Participating in another HTN-related study.
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 |
|---|---|---|
| Audiotaped Counseling SessionPatients and nurses will complete audio taped counseling session at least 3 months following the baseline visit. Patients will rate quality of nurse communication skills | Behavioural | Communication Simulation |
Primary outcome
Feasibility measured by documenting total available and eligible nurses and patients approached to enroll 1 participant through final study visit
Time frame: 6 Months
Acceptability measured by % of nurses who complete the simulation
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 14 Feb 2022.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices). Will be used for secondary data analysis approved by the investigator
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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.
Antoinette Schoenthaler, MD study director
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Audiotaped Counseling Session in people with High Blood Pressure and Hypertension, run by NYU Langone Health 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 10 inclusion and 3 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 14 Feb 2022. 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?
Feasibility measured by documenting total available and eligible nurses and patients approached to enroll 1 participant through final study visit (time frame: 6 Months). The study lists 2 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 14 Feb 2022.