| CTRI Number |
CTRI/2018/07/015036 [Registered on: 24/07/2018] Trial Registered Prospectively |
| Last Modified On: |
23/07/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clustered randomized control trial to assess the effectiveness of an interventional package on treatment adherence of hypertensive patients |
|
Scientific Title of Study
|
A clustered randomized control trial to assess the effectiveness of an interventional package on treatment adherence of hypertensive patients residing in community setting UT, Chandigarh (2017- 19) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
kmendalin Nongspung |
| Designation |
M.Sc nursing student |
| Affiliation |
national institute of nursing education PGIMER Chandigarh sector 12 |
| Address |
kmendalin nongspung National Institute of Nursing Education Post Graduate Institute of Medical Education and Research sector 12 Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7002703090 |
| Fax |
|
| Email |
kmendalin111@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kavita Narang |
| Designation |
lecturer |
| Affiliation |
national institute of nursing education PGIMER Chandigarh sector 12 |
| Address |
National Institute of Nursing Education Post Graduate Institute of Medical Education and Research sector 12 Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
|
| Fax |
|
| Email |
gaurikavita@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
kmendalin Nongspung |
| Designation |
M.Sc nursing student |
| Affiliation |
national institute of nursing education PGIMER Chandigarh sector 12 |
| Address |
kmendalin nongspung National Institute of Nursing Education Post Graduate Institute of Medical Education and Research sector 12 Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7002703090 |
| Fax |
|
| Email |
kmendalin111@gmail.com |
|
|
Source of Monetary or Material Support
|
| national institute of nursing education PGIMER Chandigarh |
|
|
Primary Sponsor
|
| Name |
kmendalin nongspung |
| Address |
kmendalin nongspung national institute of nursing education post graduate institute of medical education and research sector 12 Chandigarh |
| Type of Sponsor |
Other [self] |
|
|
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 |
| kmendalin nongspung |
upper primary health center |
Daddu Majra colony and Dhanas UT Chandigarh 160014
Chandigarh
CHANDIGARH |
7002703090
kmendalin111@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institute ethics committee post graduate institute of medical education and research Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
hypertensive patients taking treatment , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
behavioral intervention and self management intervention |
intervention group-
counselling motivation (at 2 weeks, at 4 weeks at 7weeks at 11 weeks) telephonic calls(every 7days), diary maintenance
|
| Comparator Agent |
control group |
the control group will not be getting any intervention |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
all known cases of hypertension receiving treatment |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| adherence to treatment by following medical advices related to medication, diet, exercise, follow up |
4months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| adherence to treatment |
4months |
|
|
Target Sample Size
|
Total Sample Size="250"
Sample Size from India="250"
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)
|
01/08/2018 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a clustered randomizedcontrol trial to assess the effectiveness of an interventional package on treatment adherence of hypertensive patients will be conducted in Daddu Mjra colony and Dhanas using behavioral and self managemant intervention with a sample of 250. |