| CTRI Number |
CTRI/2025/12/099615 [Registered on: 22/12/2025] Trial Registered Prospectively |
| Last Modified On: |
18/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Familys knowledge on polypharmacy and its relationship with perceived support and medication adherence among elderly |
|
Scientific Title of Study
|
A descriptive study to assess the knowledge of the family member on
polypharmacy, perceived family support and medication adherence among elderly attending the
outpatient department of tertiary care hospital of Udupi District, Karnataka |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Divya Santhosh Shetty |
| Designation |
MSc Nursing |
| Affiliation |
Manipal College of Nursing Manipal Academy of Higher Education Manipal |
| Address |
4th floor Room no 400
Department of Medical Surgical Nursing
Manipal College of Nursing Manipal Academy of Higher Education Manipal Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
8792655545 |
| Fax |
|
| Email |
diyashettyudupi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shalini G Nayak |
| Designation |
Assistant Professor Senior Scale |
| Affiliation |
Manipal College of Nursing Manipal Academy of Higher Education Manipal |
| Address |
5th floor Room no 500
Department of Medical Surgical Nursing
Manipal College of Nursing
Manipal Academy of Higher Education Manipal Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
9481375675 |
| Fax |
|
| Email |
Shalini.mcon@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Mrs Sweety Jousline Fernandes |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College of Nursing Manipal Academy of Higher Education Manipal |
| Address |
6th floor Room no 600
Department of Medical Surgical Nursing
Manipal College of Nursing
Manipal Academy of Higher Education Manipal Udupi
KARNATAKA
576104
India
Udupi
KARNATAKA
576104
India |
| Phone |
9945797188 |
| Fax |
|
| Email |
sweety.fernandes@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal College of Nursing Manipal Academy of Higher Education Manipal Udupi Karnataka India 576104 |
|
|
Primary Sponsor
|
| Name |
Divya Santhosh Shetty |
| Address |
Manipal College of Nursing Manipal Academy of Higher Education Manipal Udupi Karnataka |
| 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 |
| Dr Raghavendra Rao |
Kasturba Hospital Manipal |
Out patient department 2nd floor Kasturba Hospital Madhava Nagara Manipal 576104
Udupi
KARNATAKA |
9901731924
rags.rao@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee 2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E00-E89||Endocrine, nutritional and metabolic diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
65.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Elderly patients with polypharmacy and receiving treatment at the tertiary care hospital
Family member who escorts the elderly patient and residing together at least for three months
Elderly and family member able to communicate and write in Kannada or English
Elderly patient who takes more than five drugs in a day
|
|
| ExclusionCriteria |
| Details |
Elderly patient with Psychiatric disorders will be notified by checking their prescription
Cognitive impairment
Consuming herbal supplements
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The purpose of this study is to assess the knowledge of the family members regarding polypharmacy and perceived family support and medication adherence in elderly patients These results will be useful in identifying knowledge gaps the contribution of family support and possible medication adherence issues to better medication management for elderly patient that may increase the health compliance |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="214"
Sample Size from India="214"
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)
|
30/12/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 descriptive study to assess the knowledge of the family members on polypharmacy perceived family support and medication adherence among elderly attending the outpatient department of Tertiary care Hospital of Udupi District Karnataka The purpose of this study is to assess the knowledge of the family members regarding polypharmacy and perceived family support and medication adherence in elderly patients This study chosen to check the elderly who are taking more than 5 medications in a day and whether they are taking it on time or not The family members are aware about the medication adherence their role in medication that will be assessed These results will be useful in identifying knowledge gaps, the contribution of family support and possible medication adherence issues to better medication management for elderly patient that may increase the health compliance The objectives of the study are to assess the knowledge among the family member with polypharmacy by structured knowledge questionnaire to assess the family support among the elderly on medication adherence by using the Likert scale assess the medication adherence among the elderly by using the standardized tool Adherence to Refills and Medication Scale to find the relationship between knowledge of polypharmacy among family members and medication adherence among elderly to find the relationship between perceived family support and medication adherence among elderly Quantitative research approach and descriptive cross sectional survey design will be used to collect the data by using purposive sampling technique from 214 elderly patients and their family member who will be accompanying the elderly patient to the Kasturba Hospital Manipal The validity of tool was established by the seven experts Main data collection is planned after getting approval from administrative permission CTRI registration and informed consent from each participant after explaining the subject information sheet After getting informed consent demographic proforma structured knowledge questionnaire Likert scale Adherence to Refill and Medication Scale tools will be administered to the participants The data will be analyzed by using descriptive and inferential statistics based on objectives of the study
|