| CTRI Number |
CTRI/2025/09/094749 [Registered on: 15/09/2025] Trial Registered Prospectively |
| Last Modified On: |
12/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study showing patterns of cognitive Function, medical adherence and health literacy in relation to hypertension in elderly |
|
Scientific Title of Study
|
Cognitive function, Health Literacy, and Medication Adherence in Elderly Hypertensive patients |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Muskan |
| Designation |
Second year MBBS student |
| Affiliation |
RUHS college of medical sciences, Jaipur |
| Address |
RUHS college of medical sciences, Sector 11, kumbha Marg, Pratap Nagar, Jaipur, Rajasthan
Jaipur
RAJASTHAN
302033
India |
| Phone |
9306042886 |
| Fax |
|
| Email |
mdhayal2004@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Sonali sharma |
| Designation |
Senior professor |
| Affiliation |
RUHS college of medical sciences, Jaipur |
| Address |
Department of Biochemistry, second floor, RUHS college of medical sciences, Sector 11, kumbha Marg, Pratap Nagar ,Jaipur, Rajasthan
Jaipur
RAJASTHAN
302033
India |
| Phone |
9414314678 |
| Fax |
|
| Email |
sonalisharma14@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Sonali Sharma |
| Designation |
Senior Professor |
| Affiliation |
RUHS college of medical sciences, Jaipur |
| Address |
Department of Biochemistry, second floor, RUHS college of medical sciences, Sector 11, kumbha Marg, Pratap Nagar, Jaipur, Rajasthan
Jaipur
RAJASTHAN
302033
India |
| Phone |
9414314678 |
| Fax |
|
| Email |
sonalisharma14@gmail.com |
|
|
Source of Monetary or Material Support
|
| Infrastructural support (only): RUHS and associated hospitals, sector 11, kumbha marg, pratap nagar, jaipur |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [] |
|
|
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 Sonali Sharma |
RUHS College of Medical Sciences |
General Medicine Department, RUHS College of Medical sciences, sector 11, Kumbha Marg, pratap nagar, Jaipur , Rajasthan
Jaipur
RAJASTHAN |
9414314678
sonalisharma14@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee of RUHS College of Medical Sciences |
Approved |
|
|
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 |
| Intervention |
nil |
nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Participants of age 60 years and above.
2. Diagnosed with hypertension( Blood pressure 140/90mmHg) or currently on antihypertensive
medication.
3.Participants must have primary education ,they should be able to read and write in Hindi and
english language.
4.Participants those who give written informed consent. |
|
| ExclusionCriteria |
| Details |
1.History of stroke, dementia and other neurological disorders affecting cognitive function.
2.Current use of medication known to significantly affecting cognitive function(Certain
antipsychotic and anticholinergic).
3.Acute illness and hospitalisation in the past month.
4.Severe visual and hearing impairment that may interfere with cognitive assessment. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To assess the prevalence of cognitive impairment among elderly hypertensive patients.
2.To assess knowledge about disease and health literacy among elderly hypertensives
3. To evaluate the association between cognitive function and health literacy and medication
adherence in elderly hypertensive patients. |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Identify specific cognitive domains that are most strongly associated with medication adherence
in elderly hypertensive patients.
2.Explore influence of sociodemographic factors (age, education, social support) on the relationship
between cognitive function and medication adherence.
3. To assess the impact of health literacy on medication adherence and cognitive outcomes in this
population. |
2 months |
|
|
Target Sample Size
|
Total Sample Size="260"
Sample Size from India="260"
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)
|
10/10/2025 |
| 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="2"
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
|
High blood pressure is a chronic non communicable disease , considered one of the leading mortality risks in the world. prevalence of hypertension increases significantly with age, and high BP is more prevalent among elderly thanin the young and middle- aged population. Cognitive impairment has been described as an important risk factor associated with inadequate blood pressure control. Aging is associated with increased risk of cognitive decline, which may impact medication adherence and health management. While the relationship between cognitive function and medication adherence has been studied in various populations, more specific research is needed on elderly hypertensive patients. Understanding this link can inform targeted interventions to improve adherence and health outcomes in this vulnerable population. Improving medication adherence in elderly hypertensive patients can contribute to better blood pressure control, potentially reducing the burden of cardiovascular diseases. Exploring the role of social support networks in enhancing medication adherence among cognitively impaired elderly hypertensive patients will also be beneficial.This study aims to address these needs by investigating the relationship between cognitive function , health literacy and medication adherence in elderly hypertensive patients, potentially informing clinical practice and public health strategies.
|