| CTRI Number |
CTRI/2023/10/059161 [Registered on: 26/10/2023] Trial Registered Prospectively |
| Last Modified On: |
24/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Behavioral
Other (Specify) [Health Education, Regular remainder through mobile phone] |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Effect of multi-component intervention on medication adherence among non-adherent Type 2 diabetic patients |
|
Scientific Title of Study
|
Effect of multi-component intervention on medication adherence among non-adherent type 2 diabetic patients in an urban area of South India. A cluster randomized control trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gokul D |
| Designation |
Post Graduate |
| Affiliation |
Saveetha Medical College |
| Address |
Saveetha Medical College, Thandalam, Chennai,
Department of Community Medicine,
3rd floor, medical college block,
Room no 113
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
9791413129 |
| Fax |
|
| Email |
gokul.deve3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nisha B |
| Designation |
Associate Professor |
| Affiliation |
Saveetha Medical College |
| Address |
Saveetha Medical College, Thandalam, Chennai,Saveetha Medical College, Thandalam, Chennai.
Department of Community Medicine,
3rd floor, medical college block,
Room no 110
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
9884713773 |
| Fax |
|
| Email |
drnishacm2014@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gokul D |
| Designation |
Post Graduate |
| Affiliation |
Saveetha Medical College |
| Address |
Saveetha Medical College, Thandalam, Chennai.Saveetha Medical College, Thandalam, Chennai,
Department of Community Medicine,
3rd floor, medical college block,
Room no 113
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
9791413129 |
| Fax |
|
| Email |
gokul.deve3@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
Saveetha medical College |
| Address |
Saveetha Medical College and Hospital, Thandalam, Chennai 602105 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Gokul |
Saveetha Medical College |
Thandalam, Chennai, Tamil Nadu 602105,Saveetha Medical College, Thandalam, Chennai.
Department of Community Medicine,
3rd floor, medical college block
Kancheepuram
TAMIL NADU |
9791413129
gokul.deve3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Medical College and Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Health Education |
Health education regarding intake of proper diabetic diet, complications of medication non adherence, uses of regular follow up and taking medication, knowledge on long term complication.
|
| Comparator Agent |
No intervention |
NIL |
| Comparator Agent |
No intervention |
NIL |
| Intervention |
Remainders through phone call |
Regular remainders (daily) will be provided through hone call to take medication. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult individuals with Type 2 Diabetes mellitus over 18 years of age.
2. Old and newly diagnosed Type 2 diabetic patients.
3. Patients who were found to be non-adherent by MAQ scores of 1-4 presenting to the study setting for further management will be included in the study
|
|
| ExclusionCriteria |
| Details |
1. Person not willing to participate in the study.
2. Pregnant, lactating and trying to become pregnant.
3. Malignancy or life-threatening diseases.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Blood glucose level (mg/dl) |
6months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Blood glucose level (mg/dl) |
0 and 3rd month of study |
|
|
Target Sample Size
|
Total Sample Size="124"
Sample Size from India="124"
Final Enrollment numbers achieved (Total)= "252"
Final Enrollment numbers achieved (India)="252" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
06/11/2023 |
| Date of Study Completion (India) |
30/06/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Diabetes is one of the most significant health problem and the most common chronic metabolic disease in the world and it is expected to be the 7th leading cause of death worldwide by 2030. There are only few interventional studies related to medication non adherence among type 2 Diabetes Mellitus patient in south India, hence this study has been done to evaluate the effectiveness of multicomponent intervention on medication non adherence in type 2 Diabetes Mellitus. I will sent for publication once the trial is completed |