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

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
PACTR
Registry ID
PACTR202003783697033
Enrollment
406
Registered
2020-03-30
Start date
2020-01-13
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Circulatory System Nutritional, Metabolic, Endocrine

Interventions

BP device plus behavior intervention A
BP device plus behavior intervention B
BP device no behavior intervention C
Glucometer device plus behavior intervention
Glucometer device but no behavior intervention

Sponsors

Sanofi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Mean change in systolic blood pressure;Mean change in diastolic blood pressure ;Mean change in fasting blood sugar/HbA1c<7%

Secondary

MeasureTime frame
Frequency of measuring blood pressure;Frequency of measuring blood sugar;Cost-effectiveness of the intervention;Acceptability of the intervention by patients

Countries

Kenya

Contacts

Public ContactGershim Asiki

Research Scientist African Population and Health Research Center

gasiki@aphrc.org+254204001000

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026