Evaluating a service model for management of hypertension and diabetes among low and middle- income patients enrolled on M-TIBA in Kenya

Phase 3

• Conditions: Circulatory System; Nutritional, Metabolic, Endocrine

• Registration Number: PACTR202003783697033
• Lead Sponsor: Sanofi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-01-06
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Other
• Sex: All
• Target Recruitment: 406

Inclusion Criteria

1.Patients with a new diagnosis of essential HTN or diagnosed with type 2 diabetes
2. Patients known to have essential HTN or with diabetes who are already receiving medication.
3.HTN- or diabetic patients receiving treatment provided by the recruiting site
4.Adult (> 18 years old)
5.Ownership of a phone
6.Patients paying out of pocket and willing to be enrolled on M-TIBA

Exclusion Criteria

1.Patients with (suspected) secondary HTN, as described by local guidelines. This diagnosis is at discretion of the treating physician
2.HTN-patients requiring treatment (secondary, tertiary HTN care) not provided by the recruiting site
3.Patients unwilling or who refuse to give informed consent
4.Arm circumference greater than or less than the 22-42 cm for which the used cuffs is validated
5.Failure to obtain valid BP-values (e.g. cardiac arrhythmias)
6.Pregnancy
7.Patients who are judged to be unsuitable for receipt of mobile HTN or diabetes care by the treating physicians (for instance, patients with life-threatening diseases, dementia, and illiterate patients).
8.Patients who have had an acute cardiovascular event in the previous 3 months.

Study & Design

• Study Type: Interventional
• Study Design: Not specified