Feasibility and impact of a nurse-led integrated diabetes self-management and psycho-social educational intervention among adults with type-2 diabetes in Ethiopia

A feasibility and effectiveness of a nurse-led, combined, locally contextualized integrated diabetes self-management and psycho-social educational intervention on clinical and mental health outcomes among adults with type 2 diabetes in Ethiopia: A cluster randomized controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

PACTR

Registry ID

PACTR202502718815862

Enrollment

210

Registered

2025-02-05

Start date

2025-07-01

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

Mental and Behavioural Disorders Nutritional, Metabolic, Endocrine

Interventions

New Unified and locally contextualized DSM and Psychosocial educational intervention

Standard diabetes care

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Adults aged 18–65 years. 2) Diagnosis of type 2 diabetes with or without comorbid mental health challenges. 3) Receiving diabetes care for at least six months before the trial. 4) Ability to provide informed consent and complete study procedures during study period. 5) Access to mobile phone to receive phone call/SMS reminders and notifications.

Exclusion criteria

Exclusion criteria: 1) Severe mental health disorders, cognitive impairments, or any condition preventing adherence to the protocol. 2) Severe comorbidities that interfere with participation (e.g., advanced renal disease or active cancer with life expectancy <1 year). 3) Pregnancy or plans to become pregnant during the study period. 4) Concurrent participation in other intervention-based studies that conflict with the protocol. 5) Non-residents or participants planning to relocate during the study period.

Design outcomes

Primary

Measure	Time frame
Glycemic control, measured by HbA1c levels	—

Secondary

Measure	Time frame
1) Depression and anxiety level - using PHQ-9 and GAD-7 tools respectively. 2) Health related quality of life - using SF-36 tool 3) Medication adherence - using MMAS-8 tool 4) Self-management practices - using DSMS-7 questionnaire 5) Incidence of acute diabetic complications and hospitalizations 6) Cardio-metabolic parameters (Lipid profiles, Blood pressure, Body mass Index, waist and hip circumference). 7) Adherence to, satisfaction and feedback on intervention 8) Feasibility, acceptability and scalability of the intervention	—

Measure

Time frame

1) Depression and anxiety level - using PHQ-9 and GAD-7 tools respectively. 2) Health related quality of life - using SF-36 tool 3) Medication adherence - using MMAS-8 tool 4) Self-management practices - using DSMS-7 questionnaire 5) Incidence of acute diabetic complications and hospitalizations 6) Cardio-metabolic parameters (Lipid profiles, Blood pressure, Body mass Index, waist and hip circumference). 7) Adherence to, satisfaction and feedback on intervention 8) Feasibility, acceptability and scalability of the intervention

—

Countries

Ethiopia

Contacts

Public ContactAman Endries

Assistant Professor of Epidemiology at Saint Paul Hospital Millennium Medical College

aman.yesuf@sphmmc.edu.et+251920569262

Outcome results

None listed

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