| CTRI Number |
CTRI/2024/10/075863 [Registered on: 25/10/2024] Trial Registered Prospectively |
| Last Modified On: |
21/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Observational Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Drug related problems in patients with hypertension and type 2 diabetes |
|
Scientific Title of Study
|
Assessment of drug related problems in patients with hypertension and type 2 diabetes : A prospective study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anju Mary Reji |
| Designation |
MPHARM student |
| Affiliation |
Manipal College of Pharmaceutical Sciences |
| Address |
Room no 3,
Department of Pharmacy Practice,
4th floor,
Manipal College of Dental Sciences,
Manipal Academy of Higher Education,
Manipal, Karnataka 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9061714207 |
| Fax |
|
| Email |
anju.mcopsmpl2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Leelavathi D Acharya |
| Designation |
Additional Professor |
| Affiliation |
Manipal College of Pharmaceutical Sciences |
| Address |
Room no 3,
Department of Pharmacy Practice,
4th floor,
Manipal College of Dental Sciences,
Manipal Academy of Higher Education,
Manipal, Karnataka 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9448159927 |
| Fax |
|
| Email |
leela.da@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Leelavathi D Acharya |
| Designation |
Additional Professor |
| Affiliation |
Manipal College of Pharmaceutical Sciences |
| Address |
Room no 3,
Department of Pharmacy Practice,
4th floor,
Manipal College of Dental Sciences,
Manipal Academy of Higher Education,
Manipal, Karnataka 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9448159927 |
| Fax |
|
| Email |
leela.da@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal Academy of Higher Education, Manipal, Udupi, Karnataka, India, 576104 |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [NIL] |
|
|
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 Shivashankara K N |
Kasturba Hospital Manipal |
Room no 7,
Department of General Medicine
Non-OPD,
Kasturba Medical College,
Manipal Academy of Higher Education,
Manipal, Karnataka 576104
Udupi
KARNATAKA |
9448623861
shi.sha@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee-2 (student research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I10||Essential (primary) hypertension, (2) ICD-10 Condition: I152||Hypertension secondary to endocrine disorders, (3) ICD-10 Condition: I151||Hypertension secondary to other renal disorders, (4) ICD-10 Condition: I129||Hypertensive chronic kidney disease with stage 1 through stage 4 chronic kidney disease, or unspecified chronic kidney disease, (5) ICD-10 Condition: I120||Hypertensive chronic kidney disease with stage 5 chronic kidney disease or end stage renal disease, (6) ICD-10 Condition: I169||Hypertensive crisis, unspecified, (7) ICD-10 Condition: I161||Hypertensive emergency, (8) ICD-10 Condition: I161||Hypertensive emergency, (9) ICD-10 Condition: I130||Hypertensive heart and chronic kidney disease with heart failure and stage 1 through stage 4 chronic kidney disease, or unspecified chronic kidney disease, (10) ICD-10 Condition: I132||Hypertensive heart and chronic kidney disease with heart failure and with stage 5 chronic kidney disease, or end stage renal disease, (11) ICD-10 Condition: I131||Hypertensive heart and chronic kidney disease without heart failure, (12) ICD-10 Condition: I131||Hypertensive heart and chronic kidney disease without heart failure, (13) ICD-10 Condition: I110||Hypertensive heart disease with heart failure, (14) ICD-10 Condition: I119||Hypertensive heart disease withoutheart failure, (15) ICD-10 Condition: I160||Hypertensive urgency, (16) ICD-10 Condition: I158||Other secondary hypertension, (17) ICD-10 Condition: I150||Renovascular hypertension, (18) ICD-10 Condition: I159||Secondary hypertension, unspecified, (19) ICD-10 Condition: I159||Secondary hypertension, unspecified, (20) ICD-10 Condition: E115||Type 2 diabetes mellitus with circulatory complications, (21) ICD-10 Condition: E115||Type 2 diabetes mellitus with circulatory complications, (22) ICD-10 Condition: E110||Type 2 diabetes mellitus with hyperosmolarity, (23) ICD-10 Condition: E111||Type 2 diabetes mellitus with ketoacidosis, (24) ICD-10 Condition: E112||Type 2 diabetes mellitus with kidney complications, (25) ICD-10 Condition: E114||Type 2 diabetes mellitus with neurological complications, (26) ICD-10 Condition: E113||Type 2 diabetes mellitus with ophthalmic complications, (27) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications, (28) ICD-10 Condition: E118||Type 2 diabetes mellitus with unspecified complications, (29) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Adult patient above 18 years of age of both genders who are diagnosed with T2DM or HTN and are prescribed with at least 1 anti-diabetic or 1 anti-hypertensive drug |
|
| ExclusionCriteria |
| Details |
Patients who are
Pregnant or lactating
Diagnosed with T1DM or gestational DM
Diagnosed with malignancy or autoimmune disorders |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The prescription pattern of antihypertensives and antidiabetics in the clinical settings will be understood.
DRPs associated with antihypertensive and antidiabetic prescriptions in clinical settings will be identified.
DRPs based on PCNE classification and Hepler Strand classification will be classified |
5 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
07/11/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
07/11/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Aims & objectives : To identify and categorize drug related problems in patients with hypertension and type 2 diabetes using Hepler Strand categorization and the Pharmaceutical Care Network Europe classification method (PCNE) To understand the prescription pattern of hypertension and type 2 diabetes. To identify the drug-related problems in patients with hypertension and type 2 diabetes. To classify the drug-related problems using Hepler Strand categorization and the Pharmaceutical Care Network Europe classification method (PCNE)
This prospective study will be carried out in the General Medicine Department- unit 7 of a Tertiary care hospital. Data will be collected daily through interviews with HTN and T2DM patients. A structured data collection form will be used to obtain details from patient medical records such as demographics, prescription information, medical progress notes, laboratory results. Drug related problems (DRPs) assessment will be carried out. The detection of the DRPs will be carried out through an active search following three steps. Prescription analysis: the indication and dosage will be evaluated for prescription errors (dose, frequency, and indication) and potential drug interactions Active search in medical records: the medical records will be investigated for clinical and laboratory parameters related to ineffectiveness and unreliability of medications. Classification of DRPs: The suspected identification of DRPs that occurred during the hospitalization will be classified according to the PCNE and Hepler strand classification Outcome measures: The prescription pattern of antihypertensives and antidiabetics in the clinical settings will be understood. DRPs associated with antihypertensive and antidiabetic prescriptions in clinical settings will be identified. DRPs based on PCNE classification and Hepler Strand classification will be classified.
|