HypertensionNCT02866669
Southeastern Collaboration to Improve Blood Pressure Control
A study testing Practice Facilitation and Peer Coach in people with Hypertension, run by University of Alabama at Birmingham at 3 sites in United States.
Trial summary
The central objective of this proposal is to rigorously compare two strategies designed to improve BP control in primary care practices serving rural Southeastern African Americans with low socioeconomic status (SES) living in the "Black Belt". Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Practice Facilitation and Peer Coach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,592 participants
- Where
- 3 sitesUnited States
- Study dates
- 3 May 2017to 28 Feb 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- African American adults aged 19-85 years
- Uncontrolled HTN, defined as BP >140/90 mm Hg at the time of study enrollment
- Black Belt resident
- English speaking
- Willing to work with a peer coach
- Willing to sign informed consent
Who cannot join
- Plans to move out of the area within the next two years
- Advanced illness with limited life expectancy
- Pregnant or plans to get pregnant in the next year
- Advanced chronic kidney disease (estimated glomerular filtration rate <45 ml/min/1.73 m2)
- Unwillingness to work with a peer coach or to sign informed consent
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Alabama At Birmingham
Birmingham, Alabama, 35205
UNC Chapel Hill
Chapel Hill, North Carolina, 37599
East Carolina University
Greenville, North Carolina, 27834
About this study
Official title: Collaboration to Improve Blood Pressure in the US Black Belt-addressing the Triple Threat
The central objective of this proposal is to rigorously compare two strategies designed to improve BP control in primary care practices serving rural Southeastern African Americans with low socioeconomic status (SES) living in the "Black Belt".
In year 1, we're engaging community members (community members who have experience being community peer advisors or have high blood pressure) to develop the study interventions and protocols. In years 2-5, the investigators will test the interventions.
Read more
Year 2-5, Aim 3: Enroll 80 practices and 25 African American patients with uncontrolled HTN at each practice (total n=2000) in a cluster-randomized, controlled, 4-arm pragmatic implementation trial to evaluate the three multi- component, multi-level functional interventions finalized in the UH2 phase compared with enhanced usual care.
The study's 4 arms are:
- Enhanced Usual Care: Practices are provided with educational materials and tools to enhance patient care
- Peer Coaching: Patients enrolled in these practices will be matched with a peer coach. The peer coach helps the patient to set goals around self-management, including medications, home monitoring, and diet and exercise, and she helps the patient to strategize how to accomplish the goals, using motivational interviewing techniques
- Practice Facilitation: Practices randomized to this arm will work with a practice facilitator. Practice facilitation is a highly customized, staged approach to helping a practice to implement process and structural changes to enhance the quality of care and improve patient and staff satisfaction
- Peer coaching and practice facilitation: Practices randomized to this arm will receive both the peer coach intervention and the practice facilitation intervention. Practice facilitators and peer coaches will receive the same training for this hybrid intervention, but the practice facilitator change packet will add examples of activities that integrate peer coaches.
- Conditions
- Hypertension
- Being tested
- Practice Facilitation, Peer Coach, Enhanced usual care
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Practice FacilitationBehavioural
ractices that are randomized to the practice facilitation arm will work with a practice facilitator that will help practice staff for 15 months to make practice level changes to improve hypertension control. Practice facilitation is a highly customized, staged approach to helping a practice to implement process and structural changes to enhance the quality of care and improve patient and staff satisfaction
Peer CoachBehavioural
Also called Taking Control of Your Health
Participants enrolled from practices that are randomized to the peer coach arm will be matched with peer advisors who will work with the participants for 12 months.
Enhanced usual careBehavioural
Practices in the usual enhanced care arm will receive a blood pressure medication algorithm developed using national guidelines and content experts on our study team. Practices will be provided the Joint National Committee (JNC) recommended protocol to measuring blood pressures. Practices will receive a laptop workstation that has access to the Patient Activated Learning System - an online education video system.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced usual care | Active comparator | Practices in the usual enhanced care arm will receive a blood pressure medication algorithm developed using national guidelines and content experts on our study team. Practices will be provided the Joint National Committee (JNC) recommended protocol to measuring blood pressures. Practices will receive a laptop workstation that has access to the Patient Activated Learning System - an online education video system. Receives: Behavioral: Enhanced usual care |
| Practice facilitation | Experimental | Practices that are randomized to the practice facilitation arm will work with a practice facilitator that will help practice staff for 15 months to make practice level changes to improve hypertension control. Practice facilitation is a highly customized, staged approach to helping a practice to implement process and structural changes to enhance the quality of care and improve patient and staff satisfaction Receives: Behavioral: Practice Facilitation; Behavioral: Enhanced usual care |
| Peer coach | Experimental | Participants enrolled from practices that are randomized to the peer coach arm will be matched with peer advisors who will work with the participants for 12 months. Receives: Behavioral: Peer Coach; Behavioral: Enhanced usual care |
| Peer coach and Practice facilitation | Experimental | Practices that are randomized to the practice facilitation arm will work with a practice facilitator that will help practice staff for 15 months to make practice level changes to improve hypertension control. The patients will also be matched with peer advisors who will work with the participants for 12 months. Receives: Behavioral: Practice Facilitation; Behavioral: Peer Coach; Behavioral: Enhanced usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Blood Pressure Control (Systolic Pressure Less Than 140 mm Hg and Diastolic Pressure Less Than 90 mm Hg) at 12 Months
Blood pressure (BP) control is defined as systolic pressure less than 140 mm Hg and diastolic pressure less than 90 mm Hg. Difference in BP control at 12 month follow-up between trial arms. BP was assessed in the practice by a research assistant using a standardized protocol at baseline, 6, and 12 months.
Measured: 12 months
Secondary outcomes (9)
Change in Systolic Blood Pressure Between Baseline and 12 Months
Change in systolic blood pressure between baseline and 12 months, which is analyzed by subtracting the baseline systolic BP from the 12 month systolic BP.
Measured: 12 months
Change in Satisfaction With Chronic Illness Care Between Baseline and 12 Months
Patient Assessment of Care for Chronic Conditions (PACIC) measures how patients perceive their chronic condition(s) are being managed by their health care team. Patients fill out a survey of 20 questions regarding the care of their chronic condition(s) over the last 12 months. Used a Likert scale from 1-5, where 1 signifies "None of the time" and 5 signifying "Always". PACIC was scored by summing participants' responses across all 20 items then dividing by 20. This score was calculated at baseline and 12 months follow-up. A change in score for each participant was created by subtracting the 12 months follow-up PACIC score from the baseline PACIC score.
Measured: 12 months
Change in Physical Component Summary Score (PCS) of the Short Form 12 (SF12)
Change in health related quality of life measured using self report scale Short form-12. Six questions comprise the PCS. Of the six questions, one question ranges on a 5 point Likert scale from excellent to poor. Two questions range on a 3 point Likert scale from a lot to not at all. Two questions are dichotomous as yes or no. One question ranges on a 5 point Likert scale from extremely to not at all. Different weights are applied to each item to results in scores ranging from 0-100 with higher scores indicating higher functioning.
Measured: 12 months
Change in the Mental Component Summary Score (MCS) From the Short Form 12 (SF12)
Change in health related quality of life measured using self report scale Short form-12. Six questions comprise the MCS. Of the six questions, two questions are dichotomous as yes or no. One question ranges on a 5 point Likert scale from all of the time to none of the time. Three questions range on a 6 point Likert scale from all of the time to none of the time. Different weights are applied to each item to result in a score ranging from 0-100 with higher scores indicating higher mental functioning.
Measured: 12 months
Self-reported ED Visit or Evidence of an ED Visit at Chart Review Between Baseline and 6 Months
Outcome was defined by self-reported question (yes/no) or chart review. Those who reported yes to the question, "In the past 6 months have you been seen in an ER/ED but not admitted overnight" were considered having the outcome. Data collectors looked for ED visits in patient's charts between baseline and 6 month visit. The outcome measure timeframe is between baseline and 6 months.
Measured: between baseline and 6 months
Self-reported ED Visit or Evidence of an ED Visit in Chart Review Between 6 Months and 12 Months
Outcome was defined by self-reported question (yes/no) or chart review. Those who reported yes to the question, "In the past 6 months have you been seen in an ER/ED but not admitted overnight" were considered having the outcome. Data collectors looked for ED visits in patient's charts between their 6 month and 12 month follow-up. The outcome measure timeframe is between 6 months and 12 month follow-up.
Measured: between 6 months to 12 month
Self-reported Hospitalization or Evidence of Hospitalization in Chart Review Between Baseline and 6 Months
Outcome was defined by self-reported question (yes/no) or chart review. Those who reported yes to the question, "In the past 6 months have you been hospitalized overnight?" were considered having the outcome.
Data collectors looked for hospitalization in patient's charts between baseline and 6 month visit. The outcome measure timeframe is between baseline and 6 months.
Measured: between baseline to 6 months
Self-Reported Hospitalization or Evidence of Hospitalization in Chart Review Between 6 Month and 12 Month
Outcome was defined by self-reported question (yes/no) or chart review. Those who reported yes to the question, "In the past 6 months have you been hospitalized overnight?" were considered having the outcome. Data collectors looked for hospitalizations in patient's charts between their 6 month and 12 month follow-up. The outcome measure timeframe is between 6 months and 12 month follow-up.
Measured: between 6 month to 12 month
Change in Perceived Stress
The 4-item Cohen perceived stress scale that are measured on a 5-point scale (0 = never, 1= almost never, 2 = sometimes, 3 = fairly often and 4- very often). Items 2 and 3 are reverse coded and then all for items are summed to created a total score that ranges from 0 -16. A higher score is negative indicating greater perceived stress.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2016 (estimated)
- Study start3 May 2017
- Primary completion28 Feb 2021
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,592 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Cherrington, MD, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02866669
- Sponsor's protocol ID
- X160722009
- Status last verified
- Oct 2023
- First submitted
- 13 Jun 2016
- Last updated
- 5 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Safford MM, Cummings DM, Halladay JR, Shikany JM, Richman J, Oparil S, Hollenberg J, Adams A, Anabtawi M, Andreae L, Baquero E, Bryan J, Sanders-Clark D, Johnson E, Richman E, Soroka O, Tillman J, Cherrington AL. Practice Facilitation and Peer Coaching for Uncontrolled Hypertension Among Black Individuals: A Randomized Clinical Trial. JAMA Intern Med. 2024 May 1;184(5):538-546. doi: 10.1001/jamainternmed.2024.0047.
PubMed 38497987Sutton KF, Richman EL, Rees JR, Pugh-Nicholson LL, Craft MM, Peaden SH, Soroka O, Mackey M, Cummings DM, Cherrington AL, Safford MM, Halladay JR; Southeastern Collaboration to Improve Blood Pressure Writing Group. Implementing practice facilitation in research: how facilitators spend their time guiding practices to improve blood pressure control. Implement Sci Commun. 2023 Jul 31;4(1):89. doi: 10.1186/s43058-023-00470-y.
PubMed 37525267Shikany JM, Safford MM, Cherrington AL, Halladay JR, Anabtawi M, Richman EL, Adams AD, Holt C, Oparil S, Soroka O, Cummings DM. Recruitment and retention of primary care practices in the Southeastern Collaboration to Improve Blood Pressure Control. Contemp Clin Trials Commun. 2023 Jan 16;32:101059. doi: 10.1016/j.conctc.2023.101059. eCollection 2023 Apr.
PubMed 36718176Cummings DM, Adams A, Patil S, Cherrington A, Halladay JR, Oparil S, Soroka O, Ringel JB, Safford MM. Treatment Intensity, Prescribing Patterns, and Blood Pressure Control in Rural Black Patients with Uncontrolled Hypertension. J Racial Ethn Health Disparities. 2023 Oct;10(5):2505-2512. doi: 10.1007/s40615-022-01431-2. Epub 2022 Oct 21.
PubMed 36271193Finch AJ, Ringel JB, Dargar S, Halladay J, Cene C, Cherrington A, Cummings D, Safford MM. Greater Social Functioning Associated With Lower Depressive Symptomatology Among Black Belt African Americans Enrolled in the Southeastern Collaboration to Improve Blood Pressure Control Study. Prim Care Companion CNS Disord. 2022 Feb 3;24(1):21m02988. doi: 10.4088/PCC.21m02988.
PubMed 35114739Sutton KF, Richman EL, Rees JR, Pugh-Nicholson LL, Craft MM, Peaden SH, Mackey M, Halladay JR; Southeastern Collaboration to Improve Blood Pressure Writing Group. Successful Trial of Practice Facilitation for Plan, Do, Study, Act Quality Improvement. J Am Board Fam Med. 2021 Sep-Oct;34(5):991-1002. doi: 10.3122/jabfm.2021.05.210140.
PubMed 34535524
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collaboration to Improve Blood Pressure in the US Black Belt-addressing the Triple Threat
- ClinicalTrials.gov ID
- NCT02866669
- Acronym / sponsor ID
- X160722009
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,592 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 3 May 2017 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 15 Aug 2016 (estimated)
- Results
- Posted 5 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The central objective of this proposal is to rigorously compare two strategies designed to improve BP control in primary care practices serving rural Southeastern African Americans with low socioeconomic status (SES) living in the "Black Belt".
In year 1, we're engaging community members (community members who have experience being community peer advisors or have high blood pressure) to develop the study interventions and protocols. In years 2-5, the investigators will test the interventions.
Year 2-5, Aim 3: Enroll 80 practices and 25 African American patients with uncontrolled HTN at each practice (total n=2000) in a cluster-randomized, controlled, 4-arm pragmatic implementation trial to evaluate the three multi- component, multi-level functional interventions finalized in the UH2 phase compared with enhanced usual care.
The study's 4 arms are:
- Enhanced Usual Care: Practices are provided with educational materials and tools to enhance patient care
- Peer Coaching: Patients enrolled in these practices will be matched with a peer coach. The peer coach helps the patient to set goals around self-management, including medications, home monitoring, and diet and exercise, and she helps the patient to strategize how to accomplish the goals, using motivational interviewing techniques
- Practice Facilitation: Practices randomized to this arm will work with a practice facilitator. Practice facilitation is a highly customized, staged approach to helping a practice to implement process and structural changes to enhance the quality of care and improve patient and staff satisfaction
- Peer coaching and practice facilitation: Practices randomized to this arm will receive both the peer coach intervention and the practice facilitation intervention. Practice facilitators and peer coaches will receive the same training for this hybrid intervention, but the practice facilitator change packet will add examples of activities that integrate peer coaches.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Enhanced usual care | Active comparator | Behavioral: Enhanced usual carePractices in the usual enhanced care arm will receive a blood pressure medication algorithm developed using national guidelines and content experts on our study team. Practices will be provided the Joint National Committee (JNC) recommended protocol to measuring blood pressures. Practices will receive a laptop workstation that has access to the Patient Activated Learning System - an online education video system. |
| Practice facilitation | Experimental | Behavioral: Practice Facilitation, Behavioral: Enhanced usual carePractices that are randomized to the practice facilitation arm will work with a practice facilitator that will help practice staff for 15 months to make practice level changes to improve hypertension control. Practice facilitation is a highly customized, staged approach to helping a practice to implement process and structural changes to enhance the quality of care and improve patient and staff satisfaction |
| Peer coach | Experimental | Behavioral: Peer Coach, Behavioral: Enhanced usual careParticipants enrolled from practices that are randomized to the peer coach arm will be matched with peer advisors who will work with the participants for 12 months. |
| Peer coach and Practice facilitation | Experimental | Behavioral: Practice Facilitation, Behavioral: Peer Coach, Behavioral: Enhanced usual carePractices that are randomized to the practice facilitation arm will work with a practice facilitator that will help practice staff for 15 months to make practice level changes to improve hypertension control. The patients will also be matched with peer advisors who will work with the participants for 12 months. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- African American adults aged 19-85 years
- Uncontrolled HTN, defined as BP >140/90 mm Hg at the time of study enrollment
- Black Belt resident
- English speaking
- Willing to work with a peer coach
Key exclusion criteria (5 listed)
- Plans to move out of the area within the next two years
- Advanced illness with limited life expectancy
- Pregnant or plans to get pregnant in the next year
- Advanced chronic kidney disease (estimated glomerular filtration rate <45 ml/min/1.73 m2)
- Unwillingness to work with a peer coach or to sign informed consent
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 |
|---|---|---|
| Practice Facilitationractices that are randomized to the practice facilitation arm will work with a practice facilitator that will help practice staff for 15 months to make practice level changes to improve hypertension control. Practice facilitation is a highly customized, staged approach to helping a practice to implement process and structural changes to enhance the quality of care and improve patient and staff satisfaction | Behavioural | Peer coach and Practice facilitation, Practice facilitation |
| Peer CoachAlso: Taking Control of Your HealthParticipants enrolled from practices that are randomized to the peer coach arm will be matched with peer advisors who will work with the participants for 12 months. | Behavioural | Peer coach, Peer coach and Practice facilitation |
| Enhanced usual carePractices in the usual enhanced care arm will receive a blood pressure medication algorithm developed using national guidelines and content experts on our study team. Practices will be provided the Joint National Committee (JNC) recommended protocol to measuring blood pressures. Practices will receive a laptop workstation that has access to the Patient Activated Learning System - an online education video system. | Behavioural | Enhanced usual care, Peer coach, Peer coach and Practice facilitation, Practice facilitation |
Primary outcome
Number of Participants With Blood Pressure Control (Systolic Pressure Less Than 140 mm Hg and Diastolic Pressure Less Than 90 mm Hg) at 12 Months
Time frame: 12 months
Blood pressure (BP) control is defined as systolic pressure less than 140 mm Hg and diastolic pressure less than 90 mm Hg. Difference in BP control at 12 month follow-up between trial arms. BP was assessed in the practice by a research assistant using a standardized protocol at baseline, 6, and 12 months.
9 secondary outcomes
Change in Systolic Blood Pressure Between Baseline and 12 Months
Time frame: 12 months
Change in Satisfaction With Chronic Illness Care Between Baseline and 12 Months
Time frame: 12 months
Change in Physical Component Summary Score (PCS) of the Short Form 12 (SF12)
Time frame: 12 months
Change in the Mental Component Summary Score (MCS) From the Short Form 12 (SF12)
Time frame: 12 months
Self-reported ED Visit or Evidence of an ED Visit at Chart Review Between Baseline and 6 Months
Time frame: between baseline and 6 months
Self-reported ED Visit or Evidence of an ED Visit in Chart Review Between 6 Months and 12 Months
Time frame: between 6 months to 12 month
Self-reported Hospitalization or Evidence of Hospitalization in Chart Review Between Baseline and 6 Months
Time frame: between baseline to 6 months
Self-Reported Hospitalization or Evidence of Hospitalization in Chart Review Between 6 Month and 12 Month
Time frame: between 6 month to 12 month
Change in Perceived Stress
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38497987Safford MM, Cummings DM, Halladay JR, Shikany JM, Richman J, Oparil S, Hollenberg J, Adams A, Anabtawi M, Andreae L, Baquero E, Bryan J, Sanders-Clark D, Johnson E, Richman E, Soroka O, Tillman J, Cherrington AL. Practice Facilitation and Peer Coaching for Uncontrolled Hypertension Among Black Individuals: A Randomized Clinical Trial. JAMA Intern Med. 2024 May 1;184(5):538-546. doi: 10.1001/jamainternmed.2024.0047.
- Derived from this study: PubMed 37525267Sutton KF, Richman EL, Rees JR, Pugh-Nicholson LL, Craft MM, Peaden SH, Soroka O, Mackey M, Cummings DM, Cherrington AL, Safford MM, Halladay JR; Southeastern Collaboration to Improve Blood Pressure Writing Group. Implementing practice facilitation in research: how facilitators spend their time guiding practices to improve blood pressure control. Implement Sci Commun. 2023 Jul 31;4(1):89. doi: 10.1186/s43058-023-00470-y.
- Derived from this study: PubMed 36718176Shikany JM, Safford MM, Cherrington AL, Halladay JR, Anabtawi M, Richman EL, Adams AD, Holt C, Oparil S, Soroka O, Cummings DM. Recruitment and retention of primary care practices in the Southeastern Collaboration to Improve Blood Pressure Control. Contemp Clin Trials Commun. 2023 Jan 16;32:101059. doi: 10.1016/j.conctc.2023.101059. eCollection 2023 Apr.
- Derived from this study: PubMed 36271193Cummings DM, Adams A, Patil S, Cherrington A, Halladay JR, Oparil S, Soroka O, Ringel JB, Safford MM. Treatment Intensity, Prescribing Patterns, and Blood Pressure Control in Rural Black Patients with Uncontrolled Hypertension. J Racial Ethn Health Disparities. 2023 Oct;10(5):2505-2512. doi: 10.1007/s40615-022-01431-2. Epub 2022 Oct 21.
- Derived from this study: PubMed 35114739Finch AJ, Ringel JB, Dargar S, Halladay J, Cene C, Cherrington A, Cummings D, Safford MM. Greater Social Functioning Associated With Lower Depressive Symptomatology Among Black Belt African Americans Enrolled in the Southeastern Collaboration to Improve Blood Pressure Control Study. Prim Care Companion CNS Disord. 2022 Feb 3;24(1):21m02988. doi: 10.4088/PCC.21m02988.
- Derived from this study: PubMed 34535524Sutton KF, Richman EL, Rees JR, Pugh-Nicholson LL, Craft MM, Peaden SH, Mackey M, Halladay JR; Southeastern Collaboration to Improve Blood Pressure Writing Group. Successful Trial of Practice Facilitation for Plan, Do, Study, Act Quality Improvement. J Am Board Fam Med. 2021 Sep-Oct;34(5):991-1002. doi: 10.3122/jabfm.2021.05.210140.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Practice Facilitation and Peer Coach in people with Hypertension, run by University of Alabama at Birmingham at 3 sites 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 6 inclusion and 5 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 5 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Yes. Results are posted in the registry (first posted 5 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Blood Pressure Control (Systolic Pressure Less Than 140 mm Hg and Diastolic Pressure Less Than 90 mm Hg) at 12 Months (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02866669, which also lists 6 linked publications.
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 5 Oct 2023; AzTrials last refreshed its copy on 1 Nov 2026.