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

Not Applicable

Recruiting

Conditions: Type 2 Diabetes Mellitus

Registration Number: SLCTR/2016/028

Lead Sponsor: Medical Research Institute, Sri Lanka

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: Not specified

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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]<br>

Secondary Outcome Measures

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