| CTRI Number |
CTRI/2020/08/027325 [Registered on: 23/08/2020] Trial Registered Prospectively |
| Last Modified On: |
22/08/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Other (Specify) [NURSE LED INTERVENTION] |
| Study Design |
Other |
|
Public Title of Study
|
Nurse Led Intervention Hypertension Regarding Management of Hypertension |
|
Scientific Title of Study
|
Develop and Evaluate the Effectiveness of Nurse Led Intervention Regarding Management of Hypertension in terms of Awareness, Treatment Compliance , Lifestyle and Quality of Life among Hypertensive Adults in selected villages of Ambala Distt, Haryana |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Eenu |
| Designation |
Research Scholar |
| Affiliation |
M.M College of Nursing, Mullana, Ambala |
| Address |
M.M College of Nursing, Mullana, Ambala
Ambala
HARYANA
133203
India |
| Phone |
|
| Fax |
|
| Email |
eenu.angel@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Poonam Sheoran |
| Designation |
Professor |
| Affiliation |
M.M College of Nursing, Mullana, Ambala |
| Address |
M.M College of Nursing, Mullana, Ambala
Ambala
HARYANA
133203
India |
| Phone |
|
| Fax |
|
| Email |
poonamsheoran@rediff.com |
|
Details of Contact Person
Public Query
|
| Name |
Eenu |
| Designation |
Research Scholar |
| Affiliation |
M.M College of Nursing, Mullana, Ambala |
| Address |
M.M College of Nursing, Mullana, Ambala
Ambala
HARYANA
133203
India |
| Phone |
|
| Fax |
|
| Email |
eenu.angel@gmail.com |
|
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Source of Monetary or Material Support
|
|
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Primary Sponsor
|
| Name |
Eenu |
| Address |
M.M. College of Nursing, Mullana, Ambala |
| Type of Sponsor |
Other [NA] |
|
|
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 |
| Eenu |
Selected community area |
Mullana, Ambala
Ambala
HARYANA |
9888302633
eenu.angel@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, MMDU |
Approved |
|
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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 |
| Comparator Agent |
No intervention |
Routine care |
| Intervention |
Nurse Led Intervention |
Counselling, Diet modification, Laughter therapy, Health Education will be given for 3 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Willing to participate in the study
|
|
| ExclusionCriteria |
| Details |
Not able to attend intervention
Having severe illness |
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
| Awareness,Treatment Compliance,Lifestyle and Quality of Life |
within 9 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The hypertensive patients will have awareness , good treatment compliance , improved lifestyle pattern and improved quality of life. |
At the end of 9th month data will be assessed and estimated |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
22/09/2020 |
| 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="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
Hypertension is the commonest cardiovascular disorder, posing a major public health challenge to population in socioeconomic and epidemiological transition. It is one of the major risk factor for cardiovascular mortality, which accounts for 20-50% of all deaths. The nurses’ educational role has been expanded to make a major contribution to improved patients’ lifestyle behaviors, physical activity, weight, stress relief. OBJECTIVES: 1. To develop and validate nurse led intervention regarding management of hypertension
2. To assess and compare the awareness, treatment compliance, lifestyle and quality of life among hypertensive adults regarding management of hypertension before and after the administration of nurse led intervention in experimental and comparison group
3. To determine the relationship between awareness, treatment compliance , lifestyle and quality of life among hypertensive adults in experimental and comparison group
4.. To determine the association of awareness , treatment compliance , lifestyle and quality of life with selected variables among hypertensive adults in experimental and comparison group. HYPOTHESES:
H1 : There will be a significant difference in mean post test awareness , treatment compliance, lifestyle and quality of life score among hypertensive adults in experimental and comparison group H2 : There will be a significant difference between mean pretest and post test awareness score among hypertensive adults in experimental and comparison group
H3 : There will be a significant difference between mean pretest and post test treatment compliance score among hypertensive adults in experimental and comparison group H4: There will be a significant difference between mean pretest and post test lifestyle score among hypertensive adults in experimental and comparison group
H5: There will be a significant difference between mean pretest and post test quality of life score among hypertensive adults in experimental and comparison group H6: There will be a significant relationship between awareness score, treatment compliance, lifestyle and quality of life score among hypertensive adults in experimental and comparison group H7: There will be a significant association of mean awareness score, treatment compliance score, lifestyle score and quality of life score among hypertensive adults with selected variables in experimental and comparison group
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