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Effectiveness of an intervention package to improve compliance to pills among patients with type 2 diabetes mellitus: A randomized controlled trial

Effectiveness of a patient focused intervention to improve adherence to oral hypoglycemic medication among patients with type 2 diabetes mellitus in Colombo North Teaching Hospital: A randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
SLCTR
Registry ID
SLCTR/2016/028
Enrollment
Unknown
Registered
2016-11-02
Start date
2016-11-02
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Type 2 Diabetes Mellitus

Interventions

The study will be carried out in selected clinics of the Colombo North Teaching Hospital. Stratified cluster randomized sampling will be used to allocate patients into the two study arms. The inte

Sponsors

Medical Research Institute, Sri Lanka
Lead Sponsor
Sri Lanka Medical Association
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adult patients aged > 18 – 65 years 2. Diagnosed with type 2 diabetes mellitus and registered with the clinic in 2014 3. Only on oral anti-diabetic medications 4. Identified as having low adherence using a purpose designed validated tool (modified from internationally validated tools and containing key components of pill counts, self-reported number of pills ingested, HbA1C, regularity of clinic visits, regular measuring of FBS/PPBS etc.)

Exclusion criteria

Exclusion criteria: 1. Patients who are on insulin 2. Patients who are unable to attend the clinic in person due to mobility or other impairment 3. Diagnosed psychiatric illness

Design outcomes

Primary

MeasureTime frame
Change in the level of adherence to medication as measured by the validated tool designed for this study [At baseline (pre-intervention) and at 3 months and six months after the commencement of the intervention]

Secondary

MeasureTime frame
1. Reduction in the dosage/number of pills prescribed (as recorded in clinic prescriptions) 2. Rate of initiation of insulin (as recorded in clinic prescriptions) 3. Increase in knowledge about diabetes and medication (using a pre-tested questionnaire) 4. Glycemic control as measured by routine FBS/PPBS (as recorded in clinic prescriptions) 5. Symptoms attributed to hypo/hyperglyceamia (patient self-reports and medical records)) 6. Recurrent hospital/GP visits (patient self-reports and medical records) [At baseline (pre-intervention) and at 3 months and six months after the commencement of the intervention.]

Countries

Sri Lanka

Contacts

Public ContactDr. Subha Perera

Registrar in Community Medicine

perera.subha3@gmail.com

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 9, 2026