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
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SLCTR Registration Number
SLCTR/2016/028
Date of Registration
The date of last modification
Mar 03, 2019
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 or Health Condition(s) Studied
Type 2 Diabetes Mellitus
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
U1111-1187-4097
Any other number(s) assigned to the trial and issuing authority
P/184/11/2015 (ERC: Kelaniya)
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/practice
Assignment
Parallel
Purpose
Health services research
Study Phase
Not Applicable
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
Exclusion criteria
Primary outcome(s)
|
1.
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 outcome(s)
|
1.
|
[ At baseline (pre-intervention) and at 3 months and six months after the commencement of the intervention. ] |
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
Date of first enrollment
2017-03-28
Date of study completion
Recruitment status
Recruiting
Funding source
SLMA (health policy grant 2015- for HbA1C in phase1), Medical Research Institute, Sri Lanka (Grant no: 57/2015)
Regulatory approvals
Status
Approved
Date of Approval
2015-11-17
Approval number
P/184/11/2015
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Kelaniya |
| Institutional Address: | PO Box 6, Thalagolla Road, Ragama Sri Lanka |
| Telephone: | +94-11-2961267 |
| Email: | erckelaniya@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr. Subha Perera
Registrar in Community Medicine
Anti Leprosy Campaign, Welisara, Ragama,
Sri Lanka
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
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
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not available
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
