Home » Trials » SLCTR/2016/028


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 -

SLCTR Registration Number

SLCTR/2016/028


Date of Registration

02 Nov 2016

The date of last modification

Mar 16, 2017



Application Summary


Scientific Title of 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


Public Title of Trial

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


Disease of Health Condition(s) Studied

Type 2 Diabetes Mellitus


Scientific Acronym

None


Public Acronym

None


Brief title

None


Universal Trail Number

U1111-1187-4097


Any other number(s) assigned to the trial and issuing authority

P/184/11/2015 (ERC: Kelaniya)


Trial Details


What is the research question being addressed?

Is a practitioner and patient focused intervention to enhance adherence to diabetic medication, implemented in a tertiary care hospital effective?


Type of study

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Masking not used


Control

Standard therapy


Assignment

Parallel


Purpose

Health services research


Intervention(s) planned

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 intervention arm will receive a purpose designed intervention package to improve compliance, comprising

(1) A sticker on the medical records denoting low adherence, in order to sensitize the medical officers.

(2) Health education sessions: Patients will be invited to participate interactive health education sessions with teach back method.

• There will be a total of two sessions over a period of 1 month, each session lasting 30 minutes - 1 hour

• Each session would include 5-6 patients.

• The second session will be conducted with the participation of a family member/care giver.

• Those who are unable to participate in the face-to-face sessions will be contacted via telephone and instructions given to monitor adherence to medication.

• Intervention would include a PowerPoint presentation regarding natural history of the disease, how the medication acts and the importance of communicating with the doctor about side effects/ actual number of pills the patient consumes and role of care givers in medication adherence

(3) A peer support group will be established in the intervention arm of each clinic with mutual telephone numbers in a pair and the contact number of the nurse. Nursing officer will be educated regarding adherence to medication, their side effects and importance of continuation of medicine. Nursing officer will be provided with a mobile phone with a connection where she would be available on line during working hours.

The interventions will be delivered by the Principal Investigator together with the Health Education Nursing Officer of each clinic.

The control arm will receive the usual care in accordance with the standard guidelines used by the clinic. Patients in Medical/VP OPD clinics would not receive a single heath education session in clinics while diabetic clinic patients would receive a single one to one health education session at the registration of the clinic.


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


Primary outcome(s)

Change in the level of adherence to medication as measured by the validated tool designed for this study


Primary outcome(s) - Time of assessment(s)

At baseline (pre-intervention) and at 3 months and six months after the commencement of the intervention


Secondary outcome

  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)

Secondary outcome(s) - Time of assessment(s)

  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)


Target number/sample size

176 (88 in each arm)


Countries of recruitment

Sri Lanka


Anticipated start date

2016-11-02


Anticipated end date

2017-05-15


Recruitment status

Pending


State of ethics review approval

Approved by the Faculty of Medicine, University of Kelnaiya on 18/11/2015 (Ref: P/184/11/2015) under the title “ Intervention to improve adherence to medication among patients with type 2 diabetes mellitus in Colombo North Teaching Hospital and a model to


Funding source

SLMA (health policy grant 2015- for HbA1C in phase1), Medical Research Institute, Sri Lanka (Grant no: 57/2015)



Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

Dr. Subha Perera
Registrar in Community Medicine
Anti Leprosy Campaign, Welisara, Ragama, Sri Lanka

Mob: 0716667842

perera.subha3@gmail.com

Contact Person for Public Queries

Prof. Chrishantha Abeysena
Professor
Department of Public Health, Faculty of Medicine, University of Kelaniya, Ragama, Sri Lanka

Mob: 0710822848

chrishanthaabeysena@yahoo.com


Primary study sponsor/organization

Medical Research Institute, Sri Lanka

PO Box 527, Dr Danister De Silva Mawatha, Colombo 8, Sri Lanka
Tel: 0112693533


http://www.mri.gov.lk/

Secondary study sponsor (If any)

Sri Lanka Medical Association

No. 6, Wijerama Mawatha, Colombo 7, Sri Lanka
Tel: 0112693324

office@slma.lk
www.slma.lk