Practice-Based Trial of Home BP Telemonitoring Among Minority Stroke Survivors

NCT ID: NCT02011685

Last Updated: 2022-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 450 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-18
• Study Completion Date: 2019-12-31

Brief Summary

This study will assess the comparative effectiveness, cost-effectiveness and sustainability of two telemonitoring interventions in reducing blood pressure and recurrent stroke among 450 high-risk Black and Hispanic stroke patients. The primary hypothesis is that home blood pressure telemonitoring supplemented with individualized, culturally tailored telephone-based nurse case management will have greater effects on blood pressure reduction and stroke recurrence and, while it will be more costly, it will also be more cost-effective than home blood pressure telemonitoring alone. Results of this study will provide strong empirical evidence to inform clinical guidelines and practice, which may lead to reductions in stroke disparities in the United States.

Conditions

Stroke; Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Home BP Telemonitoring (HBPTM)

Participants will take home BP readings 3 days per week (morning and evening) for one week out of each month during the 12-month intervention.

Group Type: ACTIVE_COMPARATOR

Home BP Telemonitoring (HBPTM)

Intervention Type: BEHAVIORAL

Participants will take home BP readings 3 days per week (morning and evening), one week out of every month for 12 months. BP readings will be transmitted wirelessly to a secure server. Patients' physicians will receive home BP reports via secure email before every scheduled appointment for the duration of the study to facilitate necessary treatment intensification and medication adjustments.

HBPTM + Nurse Case Management (NCM)

Participants will complete the same Home BP Telemonitoring protocol and will also complete 20 counseling phone calls with a nurse case manager during the 12-month intervention.

Group Type: EXPERIMENTAL

Home BP Telemonitoring (HBPTM)

Intervention Type: BEHAVIORAL

Participants will take home BP readings 3 days per week (morning and evening), one week out of every month for 12 months. BP readings will be transmitted wirelessly to a secure server. Patients' physicians will receive home BP reports via secure email before every scheduled appointment for the duration of the study to facilitate necessary treatment intensification and medication adjustments.

Nurse Case Management (NCM)

Intervention Type: BEHAVIORAL

Participants will complete 20 counseling phone calls with a nurse case manager (NCM) during the 12-month intervention: weekly calls for Months 1-2; biweekly calls for Months 3-4; and monthly calls for Months 5-12. The NCMs will provide self-management education, medication and appointment reminders, and will facilitate patient-provider communication. They will counsel patients on specific self-management behaviors using problem solving and motivational interviewing techniques. Target behaviors will include dietary changes, physical activity, weight loss, medication adherence, and smoking cessation. NCMs will also review patients' clinical information and provide feedback about abnormal lab results, and will communicate with the patient's physician as needed (e.g., regarding barriers).

Interventions

Home BP Telemonitoring (HBPTM)

Participants will take home BP readings 3 days per week (morning and evening), one week out of every month for 12 months. BP readings will be transmitted wirelessly to a secure server. Patients' physicians will receive home BP reports via secure email before every scheduled appointment for the duration of the study to facilitate necessary treatment intensification and medication adjustments.

Intervention Type: BEHAVIORAL

Nurse Case Management (NCM)

Participants will complete 20 counseling phone calls with a nurse case manager (NCM) during the 12-month intervention: weekly calls for Months 1-2; biweekly calls for Months 3-4; and monthly calls for Months 5-12. The NCMs will provide self-management education, medication and appointment reminders, and will facilitate patient-provider communication. They will counsel patients on specific self-management behaviors using problem solving and motivational interviewing techniques. Target behaviors will include dietary changes, physical activity, weight loss, medication adherence, and smoking cessation. NCMs will also review patients' clinical information and provide feedback about abnormal lab results, and will communicate with the patient's physician as needed (e.g., regarding barriers).

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Black or Hispanic
• Age 18 years or older
• English or Spanish speaking
• Patients who have had an ischemic or hemorrhagic stroke
• Modified Rankin scale score of ≤ 3
• Average screening SBP ≥ 140 mm Hg from three BP readings taken at two separate visits with a validated automated device
• Receiving care at the study site for at least 6 months and planning to continue receiving care at the site for the next two years.

Exclusion Criteria

• Being deemed unable to comply with the study protocol (either self-selected or by indicating during screening that he/she could not complete all requested tasks including using the HBPTM or interacting with the NCM if he/she were to be randomized to the intervention group)
• Participation in other clinical trials
• Diagnosis of cognitive dysfunction or significant psychiatric comorbidity (as indicated in medical record)
• Patients with upper arm circumference ≥ 52 cm, the maximum limit of the extra-large BP cuff
• Diagnosis of dialysis or end stage renal disease
• Relocating out of area or extended travel during study period
• Significant verbal speech impairment; unable to participate in intervention telephone sessions
• Pregnant women

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role: collaborator

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

NYU School of Medicine

New York, New York, United States

Countries

United States

References

Ogedegbe G, Teresi JA, Williams SK, Ogunlade A, Izeogu C, Eimicke JP, Kong J, Silver SA, Williams O, Valsamis H, Law S, Levine SR, Waddy SP, Spruill TM. Home Blood Pressure Telemonitoring and Nurse Case Management in Black and Hispanic Patients With Stroke: A Randomized Clinical Trial. JAMA. 2024 Jul 2;332(1):41-50. doi: 10.1001/jama.2024.6609.

Reference Type: DERIVED

PMID: 38842799 (View on PubMed)

Spruill TM, Williams O, Teresi JA, Lehrer S, Pezzin L, Waddy SP, Lazar RM, Williams SK, Jean-Louis G, Ravenell J, Penesetti S, Favate A, Flores J, Henry KA, Kleiman A, Levine SR, Sinert R, Smith TY, Stern M, Valsamis H, Ogedegbe G. Comparative effectiveness of home blood pressure telemonitoring (HBPTM) plus nurse case management versus HBPTM alone among Black and Hispanic stroke survivors: study protocol for a randomized controlled trial. Trials. 2015 Mar 15;16:97. doi: 10.1186/s13063-015-0605-5.

Reference Type: DERIVED

PMID: 25873044 (View on PubMed)

Other Identifiers

U54NS081765-5162

Identifier Type: OTHER

Identifier Source: secondary_id

U54NS081765

Identifier Type: NIH

Identifier Source: secondary_id

View Link

13-00281

Identifier Type: -

Identifier Source: org_study_id