| CTRI Number |
CTRI/2026/01/101432 [Registered on: 19/01/2026] Trial Registered Prospectively |
| Last Modified On: |
16/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study to assess if emotional support delivered by volunteers in the community decreases BP in people with hypertension. |
|
Scientific Title of Study
|
Assessment of a psychological intervention by community health volunteers for hypertension in rural settings in Alappuzha in Kerala - A Pilot Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chitra Venkateswaran |
| Designation |
Adjunct Faculty |
| Affiliation |
Department of Community Medicine, Amrita Viswa Vidyapeetham, Amrita Institute of Medical Sciences Kochi Campus |
| Address |
Department of Community Medicine, Amrita Viswa Vidyapeetham, Amrita Institute of Medical Sciences (AIMS), Ponekkara, North, PO Brahmasthanam, Amrita Nagar, Edappally, Kochi, Ernakulam, Kerala
Ernakulam
KERALA
682024
India |
| Phone |
9349113654 |
| Fax |
|
| Email |
chitven@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chitra Venkateswaran |
| Designation |
Adjunct Faculty |
| Affiliation |
Department of Community Medicine, Amrita Viswa Vidyapeetham, Amrita Institute of Medical Sciences Kochi Campus |
| Address |
Department of Community Medicine, Amrita Viswa Vidyapeetham, Amrita Institute of Medical Science (AIMS), Ponekkara, North, PO Brahmasthanam, Amrita Nagar, Edappally, Kochi, Ernakulam, Kerala
Ernakulam
KERALA
682024
India |
| Phone |
9349113654 |
| Fax |
|
| Email |
chitven@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chitra Venkateswaran |
| Designation |
Adjunct Faculty |
| Affiliation |
Department of Community Medicine, Amrita Viswa Vidyapeetham, Amrita Institute of Medical Sciences Kochi Campus |
| Address |
Department of Community Medicine, Amrita Viswa Vidyapeetham, Kochi, North, PO Brahmasthanam, Amrita Nagar, Edappally, Kochi, Ernakulam, Kerala
Ernakulam
KERALA
682024
India |
| Phone |
9349113654 |
| Fax |
|
| Email |
chitven@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amrita Viswa Vidyapeetham, Amrita Institute of Medical Sciences (AIMS), Ponekkara, North, PO Brahmasthanam, Amrita Nagar, Edapally, Kochi, Ernakulam, Kerala 682024 |
| Harvard T.H Chan School of Public Health, Department of Global Health and Population, 665 Huntington Ave, MA 02115, Boston, Massachusetts, USA |
|
|
Primary Sponsor
|
| Name |
Harvard TH Chan School of Public Health |
| Address |
Department of Global Health and Population, 665 Huntington Ave, MA 02115, Boston, Massachusetts, USA |
| Type of Sponsor |
Research institution |
|
|
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 Chitra Venkateswaran |
Muhamma Panchayat |
Muhamma Panchayat, Alappuzha District, Kerala, India Pincode:688525
Ernakulam
KERALA |
9349113654
chitven@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Ethics Committee of Amrita School of Medicine |
Approved |
| Local No Objection Certificate |
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 |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Psychological Intervention for Hypertensive Patients |
The psychological intervention is delivered to the hypertensive patients by the Community Health Volunteers of Muhamma Panchayat, Alappuzha, Kerala |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1) Adults over 30 years and above and below or equal to 75 years will be recruited who have been diagnosed with Hypertension and are on Antihypertensive medication and / or lifestyle measures.2) The diagnosis of Hypertension by the Physician is made when the mean of three BP measurements recorded 5 minutes apart with Diastolic BP greater than or equal to 90 mm Hg and/ or Systolic BP greater than 140 mm Hg. |
|
| ExclusionCriteria |
| Details |
1)Those above 75 years, 2)Those with BP greater than or equal to 180/100 mm Hg, 3)Those who have had a Cerebrovascular Accident (CVA),Severe Heart Failure (heart failure NYHA Classification 111 and IV),bedridden, difficulty in engaging with the volunteers due to physical Co morbidities /Cognitive Impairment/ Mental Illness already on /or requiring Pharmacological management will be excluded. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| BP Changes, Distress Scores, Quality of Life Scores and Adherence Scores. |
Follow Up will be immediately after the intervention and 3 months following intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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)
|
02/03/2026 |
| 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="7"
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 Psychological intervention delivered by trained Community Volunteers can decrease Blood Pressure in persons with Hypertension. The Objective of the study is to test whether and how a psychological intervention delivered by community volunteers works on people with Hypertension and obtain data on effect to design the main trial to test its effectiveness. This is a Cluster non randomised - pre and post intervention design mixed methods and study is conducted in Muhamma panchayat in Alappuzha district in Kerala. The sample size is of 160 participants, and they are selected based on the inclusion and exclusion criteria. The screening for the psychological distress will be done using DASS 21 Questionnaire, Baseline measurements include BP measurements, Quality of Life (QOL) Scores measured by EQ-5D-5L, medication adherence measured using Hill Bone Medication Adherence Scale. The intervention will be delivered by Community Health Volunteers twice. First intervention will be face to face sessions for 8 weeks. Measurements on BP, Distress, QOL and adherence will be collected immediately after the intervention. There will be a follow up intervention over phone for 8 weeks and measurements on BP, Distress, QOL and adherence will be collected following this intervention. Qualitative assessment (focus group discussions and in- depth interviews (IDI)) will be conducted with key stakeholders which include patients and family members to study process indicators. The outcome measures include Blood Pressure changes, Distress Scores, Quality of life Scores, Adherence Scores, process indicators - recruitment, retention, numbers, numbers engaged, followed up, dropped out, any adverse event, satisfaction, readiness, challenges, and barriers indicating acceptability, appropriateness, adoption and feasibility. |