| CTRI Number |
CTRI/2024/11/077502 [Registered on: 29/11/2024] Trial Registered Prospectively |
| Last Modified On: |
28/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
To see the improvement in following doctors advice in patients with diabetes mellitus and hypertension after 6 months of getting personalized messages through WhatsApp
|
|
Scientific Title of Study
|
Effectiveness of Targeted Client Communication for self-care of Diabetes Mellitus and Hypertension in Puducherry - An embedded mixed methods 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 |
Balaji R |
| Designation |
MBBS |
| Affiliation |
JIPMER |
| Address |
Room no. 4, third floor, Department of Preventive and
Social Medicine, JIPMER, Dhanvantri nagar, Gorimedu, Pondicherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8870288991 |
| Fax |
|
| Email |
balajiramatchandrin49@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Subitha L |
| Designation |
Additional Professor |
| Affiliation |
JIPMER |
| Address |
Room no. 2, third floor, Department of Preventive and
Social Medicine, JIPMER, Dhanvantri nagar, Gorimedu, Pondicherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8489216058 |
| Fax |
|
| Email |
subitha.l@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Subitha L |
| Designation |
Additional Professor |
| Affiliation |
JIPMER |
| Address |
Room no. 2, third floor, Department of Preventive and
Social Medicine, JIPMER, Dhanvantri nagar, Gorimedu, Pondicherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8489216058 |
| Fax |
|
| Email |
subitha.l@gmail.com |
|
|
Source of Monetary or Material Support
|
| JIPMER, Dhanvantri nagar, Gorimedu, Pondicherry- 605006 |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
JIPMER, Dhanvantri nagar, Gorimedu, Pondicherry- 605006 |
| Type of Sponsor |
Government medical college |
|
|
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 Balaji R |
PHC hospital, Mettupalayam |
Room number 2, public health department, NCD division, PHC Mettupalayam, Vazhudavoor road, Shanmugapuram, Puducherry-605009.
Pondicherry
PONDICHERRY |
8870288991
balajiramatchandrin49@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Directorate of Health and Family Welfare |
Approved |
| JIPMER Institutional Ethics Committee Interventional Studies |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I10||Essential (primary) hypertension, (2) ICD-10 Condition: E11||Type 2 diabetes mellitus, (3) ICD-10 Condition: E10||Type 1 diabetes mellitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Standard of care |
Monthly hospital visit for follow-up and to get medications |
| Intervention |
Targeted Client Communication |
Delivery of Targeted/individualized messages (text messages, images, short videos) on risk status, control status, reminder messages, self-care related messages (nutrition, physical activity, stress management) through WhatsApp fore 6 months duration |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Individuals aged 18 and above, on treatment for DM, HTN or both for the past 6 months who can read English/Tamil, owning a smartphone/at least one family member owning a smartphone. |
|
| ExclusionCriteria |
| Details |
People with other comorbidities like stroke |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Among people living with Diabetes Mellitus, Hypertension or both availing treatment from public health facilities in Puducherry,
1.To develop a Targeted Client Communication using smartphone (WhatsApp messaging) for improving self-care practices
2.To determine the clinical and behavioural outcomes at the end of 6 months intervention in comparison to the standard of care |
The outcomes will be assessed at baseline, 3 months and 6 months from the start of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To explore the facilitators and barriers and user engagement of the Targeted Client Communication for self-care in people living with Diabetes Mellitus, Hypertension or both availing treatment from public health facilities in Puducherry, from the patients’ and Health Care Providers’ perspective. |
after 6 months of intervention
|
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
11/12/2024 |
| 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="8"
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
|
Title: Effectiveness of Targeted Client Communication for self-care of Diabetes Mellitus and Hypertension in Puducherry - An embedded mixed methods pilot study Primary objective: Among people living with Diabetes Mellitus, Hypertension or both availing treatment from public health facilities in Puducherry, 1. To develop a Targeted Client Communication using smartphone (WhatsApp messaging) for improving self-care practices 2. To determine the clinical and behavioural outcomes at the end of 6 months intervention in comparison to the standard of care Secondary objective: To explore the facilitators and barriers and user engagement of the Targeted Client Communication for self-care in people living with Diabetes Mellitus, Hypertension or both availing treatment from public health facilities in Puducherry, from the patients’ and Health Care Providers’ perspective Study design: Non-Randomized Controlled Trial Site of study: PHC Mettupalayam Sampling: Purposive sampling for qualitative phase; Consecutive sampling for qualitative phase. Sample size: Intervention arm - 100, Standard of care arm - 100; For qualitative phase - Participants will be interviewed until data saturation. Statistical analysis: All continuous variables will be summarized as Mean with Standard Deviation or Median with Inter-Quartile Range based on normality of data. All categorical variables will be summarized as frequency with proportion. The baseline characteristics of the study participants in the two groups will be compared. A Difference-In-difference analysis will be performed to estimate the mean change in the outcome variable between the two groups over the time period. McNemar Chi-Squared test will be used to determine the change in the proportion of the outcome variable from baseline to endline between the two groups. A p-value of 0.05 will be considered for statistical significance. Qualitative analysis: The interviews will be converted into transcripts within the same day using the audio recording. Manual descriptive content analysis will be done. Transcripts will be reviewed by another person to decrease bias and increase the interpretive credibility. Any difference between the two will be resolved by discussion. Decision on coding rules and theme generation will be done using standard procedure and consensus. The findings will be reported using COnsolidated criteria for Reporting Qualitative research (COREQ). Integration will be attempted at the design stage (sampling technique) and analysis stage (joint displays) and a framework for patient engagement in digital health interventions will be developed. |