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Explore barriers, facilitators, acceptability, feasibility, and fidelity of the telemedicine management of hypertension intervention
The purpose of the current study is to conduct pre-implementation work to understand the determinants of the telemedicine management of hypertension intervention implementation, feasibility of the intervention and its tailoring, and explore potential inequitable implementation factors in African American patients to enhance the intervention's usability to inform future hybrid trial design.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telemedicine Management of Hypertension | Experimental | using home blood pressure monitoring |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telemedicine Management of Hypertension | Behavioral | Telemedicine Management of high blood pressure using home blood pressure monitoring and telemedicine based hypertension self- management support and pharmacotherapy. This will be supplemented by support from community health workers. |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability of Intervention (AIM) | Acceptability will be assessed using mixed methods from both patients and stakeholders. The study team will derive themes from relevant constructs about implementation acceptability using qualitative interviews. The study team will complement this using a quantitative measure, Acceptability of Intervention Measure (AIM), which is a validated four item generic implementation outcome measures to assess implementation acceptability. Embedded mixed methods will allow alignment in results of the qualitative and quantitative analyses to provide context, complementarity, and convergence. | Month 3 |
| Appropriateness of Intervention (IAM) | Appropriateness will be assessed using mixed methods from both patients and stakeholders. The study team will derive themes from relevant constructs about implementation appropriateness using qualitative interviews. The study team will complement this using a quantitative measure, Intervention Appropriateness Measure (IAM), which is a validated four item generic implementation outcome measures to assess implementation appropriateness. Embedded mixed methods will allow alignment in results of the qualitative and quantitative analyses to provide context, complementarity, and convergence. | Month 3 |
| Feasibility of Intervention (FIM) | Feasibility will be assessed using mixed methods from both patients and stakeholders. The study team will derive themes from relevant constructs about implementation feasibility using qualitative interviews. The study team will complement this using a quantitative measure, Feasibility Intervention Measure (FIM), which is a validated four item generic implementation outcome measures to assess implementation feasibility. Embedded mixed methods will allow alignment in results of the qualitative and quantitative analyses to provide context, complementarity, and convergence. As an additional feasibility outcome, the study team will assess the proportion of eligible and screened patients who agree to participate as well as those who decline (with reasons). | Month 3 |
| Fidelity of Intervention/implementation |
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Inclusion Criteria Patients:
Exclusion Criteria Patients:
Inclusion Criteria Stakeholders:
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| Name | Affiliation | Role |
|---|---|---|
| Yashashwi Pokharel, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42132169 | Derived | Chhetri S, Manandhar S, Seals AL, Kramer J, Pokharel Y. Determinants of Successful Implementation: A Mixed-Methods Evaluation of a Team-Based Telehealth Hypertension Management Program for Underserved Patients. J Am Heart Assoc. 2026 May 19;15(10):e047236. doi: 10.1161/JAHA.125.047236. Epub 2026 May 14. | |
| 40624567 | Derived |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | May 11, 2023 | Apr 25, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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enroll up to 10 patients/clinic
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The study team will assess implementation fidelity both at the provider level (number of contacts between patients and nurses; number of pharmacologic activations) and at the patient level (number of home blood pressure data transferred). |
| Month 3 |
| Cost Estimates | The study team will estimate cost by calculating the numbers of clinic staff needed and the time spent (by provider type) per patient as well as other resources required for implementation. The study team will document resource commitment (e.g., staff time by provider type [nurses, advanced practice providers, physicians, community health workers], equipment, support [investigative team's support for device set-up, technical and implementation help]) for cost assessments. The study team will stratify cost related to the intervention and implementation strategy. | Month 3 |
| Manandhar S, Chhetri S, Sutton D, Saha AC, Kaur S, Brown J, Williamson J, Callahan KE, Moore JB, Taylor YJ, Bosworth HB, Pokharel Y. Piloting a team-based telemedicine care for hypertension focused on Black patients. Pilot Feasibility Stud. 2025 Jul 7;11(1):95. doi: 10.1186/s40814-025-01656-y. |