Self-Management Program for Depression and High Blood Pressure Risk
(TEAM-Red Trial)
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Jennifer B. Levin
Must not be taking: Antihypertensives
Disqualifiers: Pregnancy, Hypertension, Suicide risk, others
No Placebo Group
Trial Summary
What is the purpose of this trial?The proposed project is a 24-week prospective randomized controlled trial (RCT) evaluating the effects of TargEted MAnageMent Intervention (TEAM, N=41) vs. enhanced waitlist (eWL, N=41) control in young (\<50 years) African American women who are depressed or suffering from stress, and at risk for hypertension.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently using antihypertensive medications (medications for high blood pressure).
What data supports the effectiveness of the treatment TEAM-Red for managing depression and high blood pressure risk?
Research shows that integrating depression treatment into hypertension care can improve both blood pressure control and depressive symptoms. Additionally, self-management programs and interventions that consider social factors have been effective in improving health outcomes for patients with both conditions.
12345Is the Self-Management Program for Depression and High Blood Pressure Risk safe for humans?
The available research does not provide specific safety data for the Self-Management Program for Depression and High Blood Pressure Risk, but similar team-based care programs for managing hypertension and depression have been implemented without reported safety concerns.
678910How is the TEAM-Red treatment different from other treatments for depression and high blood pressure?
TEAM-Red is unique because it integrates depression treatment into hypertension care, using a team-based approach involving Licensed Practical Nurses (LPNs) to improve both blood pressure control and depressive symptoms, unlike traditional treatments that often address these conditions separately.
1381112Eligibility Criteria
This trial is for young African-American women under 50 with depression and at risk for high blood pressure, but not yet diagnosed with it. Participants must have a BMI ≥30, HbA1c >5.75, a recent BP reading of ≥130/90 mmHg, be current smokers or have LDL levels ≥100 mg/dl.Inclusion Criteria
I am an African American woman aged 18-49.
I am an African American woman aged 18-49.
I have high blood pressure risk due to factors like being overweight, high blood sugar, high blood pressure readings, smoking, or high cholesterol.
+7 more
Exclusion Criteria
I have high blood pressure or am taking medication for it.
Unwilling/unable to provide informed consent
Pregnancy
+1 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive the TEAM-Red intervention or are placed on an enhanced waitlist control for 24 weeks
24 weeks
5 group sessions (remote)
Follow-up
Participants are monitored for changes in depression and stress levels using PHQ-9 and PSS-10 scores
12 weeks
Participant Groups
The study compares the TEAM-Red self-management program against an enhanced waitlist control over 24 weeks to see if it helps manage risks associated with hypertension in depressed Black women who are predisposed to high blood pressure.
2Treatment groups
Experimental Treatment
Group I: TEAM-RedExperimental Treatment1 Intervention
Five 60-minute group sessions with 6-10 patients. These sessions will be held weekly and delivered remotely via videoconference
Group II: Enhanced Waitlist (eWL)Experimental Treatment1 Intervention
After the week 12 follow up visit, subjects in the Waitlist group will receive the TEAM Red intervention
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University Hospitals Cleveland Medical CenterCleveland, OH
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Who Is Running the Clinical Trial?
Jennifer B. LevinLead Sponsor
American Heart AssociationCollaborator
References
Pilot trial of a licensed practical nurse intervention for hypertension and depression. [2022]Depression is a risk factor for hypertension, and risk of depression is increased substantially in patients with hypertension. Our objective was to examine whether an intervention carried out by Licensed Practical Nurses (LPNs) integrating depression treatment into care for hypertension improved blood pressure control and depressive symptoms.
Impact of Behavioral Interventions on Patient Activation in Adults with Hypertension: A Systematic Review and Meta-Analysis. [2022]Introduction: Behavioral interventions assist patients in maintaining optimal self-management of their health, especially in those at risk of certain conditions. Little is known about the effects of self-management interventions on patient activation in adults with hypertension. Therefore, this systematic review and meta-analysis aimed to evaluate how self-management strategies affect changes in activation levels in adults with hypertension. Methods: We searched online databases: PubMed, CINAHL, and Cochrane Central Register of Controlled Trials for studies published between January 2004 and May 2021. We included randomized controlled trials that assessed the effects of self-management interventions on patient activation in adults with hypertension and reported patient activation using the patient activation measure (PAM). Results: 4 Four studies (N = 1415 participants) met the inclusion criteria. In adults with hypertension, self-management interventions improved patient activation with moderate strength of evidence. A community-based self-management program, motivational interviewing strategies, and home-based patient-activated care were associated with better PAM scores than usual care. Conclusion: Our findings reinforce the need for healthcare providers to incorporate these interventions into primary care to support the adoption of recommended hypertension self-management behaviors. Future studies must focus on tailoring support to the patient's level of activation in hypertension self-management.
Factors influencing self-care among patients with primary hypertension: path analysis of mediating roles of self-efficacy and depressive symptoms. [2023]Blood pressure control requires medication adherence and lifestyle modifications. Social cognitive theory suggests social support, psychological adaptation, and self-efficacy can reinforce lifestyle modifications. This study investigated if self-efficacy was a mediator between self-rated health status (SRHS), social support, depressive symptoms, anxiety, and self-care among patients with hypertension.
Incorporating Patients' Social Determinants of Health into Hypertension and Depression Care: A Pilot Randomized Controlled Trial. [2022]The objective of this study was to carry out a randomized controlled pilot trial to test the effectiveness of an integrated intervention for hypertension and depression incorporating patients' social determinants of health (enhanced intervention) versus an integrated intervention alone (basic intervention). In all, 54 patients were randomized. An electronic monitor was used to measure blood pressure, and the nine-item Patient Health Questionnaire (PHQ-9) assessed depressive symptoms. Patients in the enhanced intervention had a significantly improved PHQ-9 mean change from baseline in comparison with patients in the basic intervention group at 12 weeks (p = 0.024). Patients in the enhanced intervention had a significantly improved systolic and diastolic blood pressure mean change from baseline in comparison with patients in the basic intervention group at 12 weeks (p = 0.003 and p = 0.019, respectively). Our pilot trial results indicate integrated care management that addresses the social determinants of health for patients with hypertension and depression may be effective.
Influence of "Hospital-Community-Family" Integrated Management on Blood Pressure, Quality of Life, Anxiety and Depression in Hypertensive Patients. [2022]To explore the Influence of "hospital-community-family" integrated management on blood pressure, quality of life, anxiety and depression in hypertensive patients.
A multi-level system quality improvement intervention to reduce racial disparities in hypertension care and control: study protocol. [2022]Racial disparities in blood pressure control have been well documented in the United States. Research suggests that many factors contribute to this disparity, including barriers to care at patient, clinician, healthcare system, and community levels. To date, few interventions aimed at reducing hypertension disparities have addressed factors at all of these levels. This paper describes the design of Project ReD CHiP (Reducing Disparities and Controlling Hypertension in Primary Care), a multi-level system quality improvement project. By intervening on multiple levels, this project aims to reduce disparities in blood pressure control and improve guideline concordant hypertension care.
A Mixed-Methods Approach for Evaluating Implementation Processes and Program Costs for a Hypertension Management Program Implemented in a Federally Qualified Health Center. [2023]Team-based care approaches are effective at improving hypertension control and have been used in clinical practice to improve hypertension outcomes. This study implemented and evaluated the Hypertension Management Program (HMP), which was originally developed in a high-resource health setting, in a health system with fewer resources and a patient population disproportionately affected by hypertension. Our objectives were to describe how a health system could adapt HMP to meet their needs and calculate total program costs. HMP uses a team-based, patient-centered approach involving clinical pharmacists who contribute to managing patients who have hypertension and ultimately preventing premature death due to uncontrolled hypertension. HMP has 10 components (e.g., EHR patient registries and outreach lists, no copayment walk-in blood pressure checks). Our project involved implementing the key components of HMP in a federally qualified health center (FQHC) in South Carolina. Adaptations from the key components of HMP were made to fit the participants' settings. A mixed-methods evaluation assessed implementation processes, program costs, and implementation facilitators and barriers. From September 2018 to December 2019, clinical pharmacists conducted 758 hypertension management visits (HMVs) with 316 patients with hypertension. Total program costs for HMP were $325,532 overall and $16,277 per month. Monthly cost per patient was $3.62. The high engagement among clinical pharmacists, along with provider engagements, followed up by the subsequent referral of patients to HMP, facilitated the implementation process. Staff members observed improvements in hypertension control, which increased participation buy-in. Barriers included staff turnover, the perception among some providers that HMP took too much time, as well as perception of HMP as a pharmacy-specific initiative. A team-based, patient-centered approach to hypertension management can be adapted for FQHCs or similar settings that serve patient populations disproportionately affected by hypertension.
Primary care physician perspectives on using team care in clinical practice. [2021]Primary care physicians were prompted to refer eligible patients with uncontrolled hypertension (HTN) to a program that offered home blood pressure telemonitoring and pharmacist care management. Understanding attitudes, barriers and facilitators, and use of team care in this program provides insight into how physicians incorporate team care into their practice.
Technology-Assisted Collaborative Care Program for People with Diabetes and/or High Blood Pressure Attending Primary Health Care: A Feasibility Study. [2021]The comorbidity of depression with physical chronic diseases is usually not considered in clinical guidelines. This study evaluated the feasibility of a technology-assisted collaborative care (TCC) program for depression in people with diabetes and/or high blood pressure (DM/HBP) attending a primary health care (PHC) facility in Santiago, Chile. Twenty people diagnosed with DM/HBP having a Patient Health Questionnaire-9 score ≥ 15 points were recruited. The TCC program consisted of a face-to-face, computer-assisted psychosocial intervention (CPI, five biweekly sessions), telephone monitoring (TM), and a mobile phone application for behavioral activation (CONEMO). Assessments of depressive symptoms and other health-related outcomes were made. Thirteen patients completed the CAPI, 12 received TM, and none tried CONEMO. The TCC program was potentially efficacious in treating depression, with two-thirds of participants achieving response to depression treatment 12 weeks after baseline. Decreases were observed in depressive symptoms and healthcare visits and increases in mental health-related quality of life and adherence to treatment. Patients perceived the CPI as acceptable. The TCC program was partially feasible and potentially efficacious for managing depression in people with DM/HBP. These data are valuable inputs for a future randomized clinical trial.
Efficacy of Hypertension Self-Management Classes Among Patients at a Federally Qualified Health Center. [2022]Structural racism has contributed to persistent racial disparities in hypertension control, with Black men suffering the highest prevalence of uncontrolled hypertension. Lincoln Community Health Center, our urban Federally Qualified Health Center (FQHC), aimed to use hypertension self-management classes to improve hypertension control among our clinic patients, particularly Black men. Patients attending classes learned about hypertension, were given blood pressure cuffs to use at home, and had the opportunity to speak to physicians in a group setting. We used a nonexperimental quality improvement intervention design to identify baseline differences between participants who attended multiple classes and those who attended only 1 class. Participants who attended multiple classes, most of whom were Black men, achieved an average blood pressure reduction of 19.1/14.8 mm Hg. Although the classes were effective, current policies around health insurance reimbursement and federal quality reporting standards hamper the ability of health care providers to implement such patient education initiatives.
Psychometric Evaluation of the Chinese Version of Hypertension Self-care Profile. [2021]Valid and reliable assessment of the multidimensional self-care of patients with hypertension is important to tailor individualized care. The Hypertension Self-care Profile (HBP SCP), which comprises behavior, motivation, and self-efficacy scales, has been widely tested in various settings.
Team-based care for improving hypertension management among outpatients (TBC-HTA): study protocol for a pragmatic randomized controlled trial. [2018]Blood pressure (BP) is poorly controlled among a large proportion of hypertensive outpatients. Innovative models of care are therefore needed to improve BP control. The Team-Based Care for improving Hypertension management (TBC-HTA) study aims to evaluate the effect of a team-based care (TBC) interprofessional intervention, involving nurses, community pharmacists and physicians, on BP control of hypertensive outpatients compared to usual care in routine clinical practice.