| CTRI Number |
CTRI/2025/02/080770 [Registered on: 18/02/2025] Trial Registered Prospectively |
| Last Modified On: |
15/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [SELF ENHANCEMENT PROGRAM] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Self enhancement programme on health behaviour among elderly |
|
Scientific Title of Study
|
A study to assess the effectiveness of self enhancement programme on health behavior among elderly residing in selected rural areas of Mullana Ambala, Haryana |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ANU GOEL |
| Designation |
NURSING STUDENT |
| Affiliation |
Maharishi Markandeshwar(Deemed to be University)Mullana, Ambala |
| Address |
MENTAL HEALTH NURSING DEPARTMENT MM COLLEGE OF NURSING, MULLANA, AMBALA,HARYANA, INDIA 133207
Ambala
HARYANA
133207
India |
| Phone |
8930332562 |
| Fax |
|
| Email |
anug1274@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
MS SONIA |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Maharishi Markandeshwar(Deemed to be University) Mullana, Ambala |
| Address |
MENTAL HEALTH NURSING DEPARTMENT MM COLLEGE OF NURSING, MULLANA,AMBALA, HARYANA, INDIA 133207
Ambala
HARYANA
133207
India |
| Phone |
9811217424 |
| Fax |
|
| Email |
sonia.mmcn@mmumullana.org |
|
Details of Contact Person
Public Query
|
| Name |
MS SONIA |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Maharishi Markandeshwar (Deemed to be University) Mullana, Ambala |
| Address |
MENTAL HEALTH NURSING DEPARTMENT MM COLLEGE OF NURSING, MULLANA, AMBALA, HARYANA, INDIA 133207
Ambala
HARYANA
133207
India |
| Phone |
9811217424 |
| Fax |
|
| Email |
sonia.mmcn@mmumullana.org |
|
|
Source of Monetary or Material Support
|
| M.M. COLLEGE OF NURSING, Maharishi Markandeshwar(Deemed to be University), Mullana, Ambala, Haryana |
|
|
Primary Sponsor
|
| Name |
MAHARISHI MARKANDESHWAR DEEMED TO BE UNIVERSITYMULLANA |
| Address |
M.M. COLLEGE OF NURSING, MULLANA, AMBALA |
| 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 |
| ANU |
Village Mullana, Ambala- Haryana |
Village MULLANA, AMBALA
Ambala
HARYANA |
08930332562
anug1274@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical commitee MMIMSR Mullana, Ambala |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
ELDERLY MALES AND FEMALES |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
| Intervention |
SELF ENHANCEMENT PROGRAMME |
A SELF-ENHANCEMENT PROGRAMME CAN HELP IN PROVIDING AWARENESS REGARDING IMPORTANCE OF PHYSICAL ACTIVITY, MAINTAINING PERSONAL HYGIENE, STRESS MANAGEMENT, IMPORTANCE OF NUTRITION AND SLEEP HYGIENE, MEDICATION ADHERENCE, REGULAR FOLLOW UPS AND IMPACT OF SMOKING AND ALCOHOL CONSUMPTION.ENHANCING SELF AWARENESS AND ENCOURAGING PREVENTIVE HEALTH BEHAVIOUR WILL IMPROVE THE OVERALL BEING OF THE ELDERLY POPULATION |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
THIS STUDY WILL INCLUDE ELDERLY WHO
-ARE HAVING AGE 60YEARS TO 75 YEARS
-WILL BE WILLING TO PARTICIPATE AND ABLE TO PROVIDE INFORMED CONSENT
-WILL BE ABLE TO UNDERSTAND AND SPEAK HINDI
-WILL BE AVAILABLE AT THE TIME OF DATA COLLECTION. |
|
| ExclusionCriteria |
| Details |
THIS STUDY WILL EXCLUDE ELDERLY HAVING SEVERE MEDICAL CONDITIONS OR TERMINAL ILLNESSES THAT COULD INTERFERE WITH THEIR PARTICIPATION IN THE SELF ENHANCEMENT PROGRAMME |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| - TO KNOW ABOUT THE HEALTH PRACTICES OF THE ELDERLY |
1 Month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| TO KNOW THE HEALTH BEHAVIOUR AMONG ELDERLY RESIDING IN MULLANA, AMABALA |
1 MONTH |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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)
|
10/03/2025 |
| 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="1"
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
|
A STUDY TO ASSESS THE EFFECTIVENESS OF SELF ENHANCEMENT PROGRAMME ON HEALTH BEHAVIOR AMONG ELDERLY RESIDING IN SELECTED RURAL AREAS OF MULLANA, AMBALA, HARYANA |