| CTRI Number |
CTRI/2024/08/072807 [Registered on: 21/08/2024] Trial Registered Prospectively |
| Last Modified On: |
08/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to determine the factors affecting treatment adherence in diabetes and hypertension among coastal community |
|
Scientific Title of Study
|
Determinants of treatment adherence to type 2 diabetes mellitus and hypertension in a coastal community A mixed method approach |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sharan VS |
| Designation |
Junior Resident |
| Affiliation |
MAHE, Manipal |
| Address |
Department of Community Medicine, KMC, MAHE, Manipal
Udupi
KARNATAKA
576103
India |
| Phone |
8220473134 |
| Fax |
|
| Email |
vssharan12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Chythra R Rao |
| Designation |
Additional professor |
| Affiliation |
Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal |
| Address |
Department of Community Medicine, KMC, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9448857793 |
| Fax |
|
| Email |
chythra.raj@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Sharan VS |
| Designation |
Junior Resident |
| Affiliation |
MAHE, Manipal |
| Address |
Department of Community Medicine, KMC, MAHE, Manipal
Udupi
KARNATAKA
576103
India |
| Phone |
8220473134 |
| Fax |
|
| Email |
vssharan12@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post graduate grant
Kasturba Medical College, MAHE, Manipal, Karnataka, India - 576104 |
|
|
Primary Sponsor
|
| Name |
KMC, MAHE, Manipal |
| Address |
Department of Community Medicine, KMC, MAHE, Manipal |
| Type of Sponsor |
Private 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 Sharan VS |
Kasturba Medical College, Manipal, Manipal Academy of higher education, Manipal |
Department of Community medicine, Tiger circle road, Madhav Nagar, Manipal - 576104
Udupi
KARNATAKA |
8220473134
vssharan12@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I10-I16||Hypertensive diseases, (2) ICD-10 Condition: E11||Type 2 diabetes mellitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Permanent residents aged 30 years or above diagnosed with type 2 diabetes mellitus and/or hypertension at least for 1 year |
|
| ExclusionCriteria |
| Details |
Patients who are unable to provide answers to the questionnaire. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Treatment adherence and non adherence among patients with type 2 diabetes mellitus and hypertension aged above 30 years |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Facilitators and barriers among patients with type 2 diabetes mellitus and hypertension aged above 30 years |
in 18 months |
|
|
Target Sample Size
|
Total Sample Size="415"
Sample Size from India="415"
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)
|
02/09/2024 |
| 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="1"
Months="6"
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
|
Objective 1 - Quantitative study:
Using convenient sampling method, 415 participants will be recruited into the study. A house-to-house
survey will be conducted. The residents diagnosed with T2DM and/or hypertension at least for 1 year
present at the time of home visit will be recruited into the study. The purpose of the visit will be explained
to the participant using Participant Information Sheet (PIS) which will be handed over to the participant
and a written Informed Consent (IC) will be obtained from all the willing participants in the native
language before recruiting them into the study.
A pre-designed semi structured questionnaire will be administered in each participant to gather data on
their socio demographic characteristics, details about substance use, information regarding their health
and medications use. Socio economic status will be assessed using Modified BG Prasad Scale 2023.
Lifestyle factors such as dietary habits will be assessed according to a survey questionnaire by Kini S
et al. The scores will be summed up and categorized as Poor (score 0-33), Satisfactory (score 34-38)
and Good (score >38).8 Physical activity will be scored according to a survey questionnaire used by
Ramachandran A et al. According to the scores obtained, physical activity will be graded as Sedentary
(score 1-17), Light (score 18-34), Moderate (score 35-51) and Heavy Physical activity (score >51).9
Stress will be assessed using Cohen’s Perceived Stress Scale 4 (PSS 4). Higher score indicates more
perceived stress.
10 Morisky Medication Adherence Scale-8 (MMAS-8) will be used to assess treatment
adherence to type 2 diabetes mellitus and hypertension. It is an adherence scale consisting of 8
questions. Out of which 7 items will be answered with a yes or no and 1 item will be a 5-point Likert
scale. The scores of the MMAS-8 range from 0 to 8. A score below 6 indicates low adherence, a score
between 6 < 8 medium adherence and a score of 8 high adherence. Due permissions will be obtained
for use of all study tools. Anthropometric measurements (Height, Weight, Waist circumference) will be
measured as per standard WHO protocol. Blood Pressure (BP) will be recorded using a digital
sphygmomanometer and classified as per JNC-8 classification.13 Random Blood Sugar (RBS) will be
measured using a glucometer. RBS>200 mg/dL will be considered as poor disease control. Objective 2 - Qualitative study:
By purposive sampling method, 12-15 participants will be requested to participate for In-Depth
Interview (IDI). 3 participants each diagnosed with type 2 diabetes mellitus and/or hypertension who
are adherent to treatment. 3 participants each diagnosed with type 2 diabetes mellitus and/or
hypertension who are non-adherent to treatment.
The interviews will be conducted at a place & time convenient to participants. An interview guide will be
designed to explore the factors of adherence and non-adherence to type 2 diabetes mellitus and
hypertension treatment. The interview guide will be constructed to broadly explore the perception of
participants about various factors related to treatment adherence and non-adherence. Probes will be
used in the interview guide to get the relevant information from the participant.
The face-to-face interview will be recorded using a voice recorder. Each session may last up to 30 - 60
mins. Consent for audio recording of the interview will be obtained prior to the IDI. Confidentiality of the
data will be maintained throughout the study. Objective 3 – Scoping Review.
The review will be conducted based on a review framework by Arskey & O’Malley, 2005.7 A search
strategy will be run through various databases (PubMed, Medline, Embase, Scopus). Identified studies
will be selected for the review after following all the steps using the software – Rayyan with two
reviewers. Duplication removal, Title/Abstract screening, Full text screening using the PRISMA
guidelines will be done. Conflicts will be resolved by the subject expert. Data Extraction and a thematic
analysis will be conducted. a) Inclusion and exclusion criteria: Objective 1 & 2 1) Inclusion criteria: Permanent residents aged 30 years or above diagnosed with type 2 diabetes
mellitus and/or hypertension at least for 1 year. 2) Exclusion criteria: Patients who are unable to provide answers to the questionnaire.
Biological material: Blood (1-2 drops of blood) for assessing Random Blood Sugar.
b) Statistical methods Objective 1 -Quantitative:
Data will be entered and analyzed using Jamovi Version 2.4.11.0. Data will be presented as percentages
& proportions. Chi square test will be used to study association of Diabetes and Hypertension treatment
adherence with control of the disease and odd’s ratio to study the strength of association. Multivariable
logistic regression will be used to identify individual risk factors. Objective 2 - Qualitative:
After interview, the recorded interviews will be translated & transcribed. Data will be indexed according
to the identified themes and sub-themes which allows clarification for the final framework and chart
according to each theme to synthesize the data and aid interpretation. Objective 3 - The review will be conducted based on a review framework by Arskey & O’Malley, 2005.7 Full text
screening using the PRISMA guidelines will be done. Conflicts will be resolved by the subject expert.
Data Extraction and a thematic analysis will be conducted. |