| CTRI Number |
CTRI/2025/05/087875 [Registered on: 29/05/2025] Trial Registered Prospectively |
| Last Modified On: |
28/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Process of Care Changes
Behavioral |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
A Study on Effectiveness of a Nurse-Led Self-Care Package on Health Outcomes Among Older Adult in Chandigarh (2024–2026) |
|
Scientific Title of Study
|
A clustered Randomized Control Trial to assess the effectiveness of Nurse-led self-care package on selected outcome variables among older adults residing at Dhanas and DMC, Chandigarh, 2024-26 |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sushila Pannu |
| Designation |
M Sc Nursing Student |
| Affiliation |
National Institute of Nursing Education,Postgraduate Institute of Medical Education and Research |
| Address |
Room no.208,National Institute of Nursing Education, Postgraduate Institute of Medical Education and Research,Chandigarh,India
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9557976918 |
| Fax |
|
| Email |
pannusilu25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kavita |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Nursing Education,Postgraduate Institute of Medical Education and Research |
| Address |
Room No.305, National Institute of Nursing Education, Postgraduate Institute of Medical Education and Research, Chandigarh, India
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9872839990 |
| Fax |
|
| Email |
gaurikavita@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kavita |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Nursing Education,Postgraduate Institute of Medical Education and Research |
| Address |
Room No.305, National Institute of Nursing Education, Postgraduate Institute of Medical Education and Research, Chandigarh, India
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9872839990 |
| Fax |
|
| Email |
gaurikavita@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Medical Education and Research |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of Medical Education and Research |
| Address |
Room no.208, National Institute of Nursing Education, Post Graduate Institute of Medical Education and Research, Chandigarh, India |
| 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 |
| Dr Kavita |
Post Graduate Institute of Medical Education and Research |
Room No.305, Community Health Nursing, National Institute of Nursing Education
Chandigarh
CHANDIGARH |
9872839990
gaurikavita@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Post Graduate Institute of Medical Education and Research,Chandigarh,Institutional Ethics Committee(Intramural) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Older adults with 70 years and above |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nurse-led self-care
package |
Intervention protocol includes nurse-led self-care package designed to improve health outcomes in older adults.The total estimated time duration of intervention is 8 weeks.Follow up will be done twice a week for initial two weeks,followed by weekly assessment upto six weeks.And Endline assessment will be done after 8 weeks.It involves a multifaceted intervention delivered through an IEC booklet and nursing guidance, focusing especially on physical and psychological well-being. The package includes components like dietary modifications, progressive muscle relaxation techniques, physical exercises, sleep hygiene, and medication adherence. The goal is to empower older adults to manage their health, minimize functional limitations, and enhance their quality of life. |
| Comparator Agent |
Routine care |
Participants in the comparator group will receive the standard medical care available to older adults in the community. This routine care encompasses usual access to primary care physicians for routine health check-ups, attention to aspects of daily living, sleep, activity, and mobility as prompted by patient concerns or physician observation during routine consultations, meaning that while general advice may be provided, there is no structured assessment or individualized plan, active intervention, or dedicated education support. |
|
|
Inclusion Criteria
|
| Age From |
70.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Male and Female above or equal to 70 years of age.
2.Willing to participate in study.
|
|
| ExclusionCriteria |
| Details |
1.Older adults with Terminally illness
2.Bedridden older adults |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Self-care practices
|
Endline assessment After 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
2.Quality of life
3.Psychological wellbeing
4.Physical wellbeing |
Endline assessment After 6 weeks |
|
|
Target Sample Size
|
Total Sample Size="240"
Sample Size from India="240"
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)
|
30/06/2025 |
| 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="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
|
The study involves a nurse led, community based self-care package to improve health outcomes in older adults 70 years and above in Dhanas and Dadu Majra Colony of Chandigarh, addressing challenges of aging process. The intervention will be delivered over six weeks, which includes nutrition education, sleep hygiene, medication adherence, physical exercise, and relaxation techniques. Using a cluster randomized controlled trial design with 240 participants, the study will assess self-care practices, physical well-being, psychological well-being, and quality of life, with data collected before and after the intervention and analyzed using descriptive and inferential statistics. The study is based on the Transtheoretical Model or Stages of Change Model, developed by Prochaska and DiClemente. The study adheres to ethical guidelines, aiming to empower elderly individuals.
|