| CTRI Number |
CTRI/2024/05/067241 [Registered on: 13/05/2024] Trial Registered Prospectively |
| Last Modified On: |
03/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Process of Care Changes
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of group counselling vs individual counselling as health education methods to reduce high blood pressure among patients with high blood pressure in rural areas. |
|
Scientific Title of Study
|
Effectiveness of group counselling compared to individual counselling as a mode of health education intervention for reduction of elevated blood pressure and its associated risk factors among rural hypertensives: An interventional 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 |
Kavuru Ravindra |
| Designation |
Postgraduate student |
| Affiliation |
Rangaraya Medical College |
| Address |
Department of Community Medicine, Government General Hospital, Rangaraya Medical College, Kakinada
East Godavari
ANDHRA PRADESH
533003
India |
| Phone |
8179508292 |
| Fax |
|
| Email |
drravin@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr B Devi Madhavi |
| Designation |
Professor and Head of the Department |
| Affiliation |
Rangaraya Medical College |
| Address |
Department of Community Medicine, Government General Hospital, Rangaraya Medical College, Kakinada
East Godavari
ANDHRA PRADESH
533003
India |
| Phone |
9885193506 |
| Fax |
|
| Email |
drdevimadhavi@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kavuru Ravindra |
| Designation |
Postgraduate Student |
| Affiliation |
Rangaraya Medical College |
| Address |
Department of Community Medicine, Government General Hospital, Rangaraya Medical College, Kakinada
East Godavari
ANDHRA PRADESH
533003
India |
| Phone |
8179508292 |
| Fax |
|
| Email |
drravin@hotmail.com |
|
|
Source of Monetary or Material Support
|
| District Medical and Health Office, Kakinada |
| Rangaraya Medical College, Kakinada |
|
|
Primary Sponsor
|
| Name |
None |
| Address |
None |
| Type of Sponsor |
Other [None] |
|
|
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 Kavuru Ravindra |
Rangaraya Medical College, Government General Hospital |
Department of Community Medicine, First floor, Near Talli Pilla Statue, Near PR Circle, GGH, Kakinada
East Godavari
ANDHRA PRADESH |
8179508292
drravin@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Rangaraya Medical College Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I10||Essential (primary) hypertension, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group counselling |
A group of 3 to 5 subjects per group will be interviewed about risk factors and control measures for hypertension. The group will be then provided counselling about hypertension and its control at the three time points:
1. At first visit: Baseline data
2. At Second visit: 1 month from baseline
3. At Third visit: 3 months from baseline.
Total duration of data collection will be for 4 months |
| Comparator Agent |
Individual counselling |
Each subject will be individually interviewed about risk factors and control measures for hypertension. She/ He will then be provided counselling individually about hypertension and its control.
Interview and counselling will be provided at the three time points:
1. At first visit: Baseline data
2. At Second visit: 1 month from baseline
3. At Third visit: 3 months from baseline.
Total duration of data collection will be for 4 months |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Consenting adults (age ≥ 30 years) attending the primary clinics diagnosed with hypertension within one year from the first day of data collection.
2. The individual should have resided in the same locality in the preceding six months and is expected to stay in the same locality for the next six months from the day of baseline-data collection.
|
|
| ExclusionCriteria |
| Details |
1. Hypertensives aged less than 30 years of age.
2. Hypertensives diagnosed more than one year ago.
3. Hypertensives with end organ damage at the time of baseline-data collection |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Blood pressure
Height, weight, BMI (Body Mass Index)- WHO-Asian classification
Knowledge score
Minutes of Physical activity per day
Practice related to diet, alcohol consumption, tobacco use
|
Baseline, 1st month from baseline, 3rd month from baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Height, weight, BMI (Body Mass Index)- WHO-Asian classification
Minutes of Physical activity per day.
Practice related to diet, alcohol consumption, tobacco use. |
Baseline, 1st month from baseline, 3rd month from baseline |
|
|
Target Sample Size
|
Total Sample Size="248"
Sample Size from India="248"
Final Enrollment numbers achieved (Total)= "240"
Final Enrollment numbers achieved (India)="240" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
22/05/2024 |
| Date of Study Completion (India) |
18/01/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
18/01/2025 |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| 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
|
This study is a randomized, open ended, parallel group, single centre community based trial comparing the effectiveness of group counselling and individual counselling as health education interventions in 248 patients diagnosed with hypertension in the last one year that will be conducted in different villages in the rural areas of Kakinada district of Andhra Pradesh state. The primary outcome measures will be blood pressure, weight, BMI, Waist-hip ratio, Physical activity levels and Knowledge score on hypertension at baseline, 1month from baseline and at 3 months from baseline. |