Phone call based educational intervention for diabetes management
| ISRCTN | ISRCTN67491047 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN67491047 |
| Secondary identifying numbers | JSSMC/11/5976/2016-17 |
- Submission date
- 28/02/2022
- Registration date
- 06/04/2022
- Last edited
- 12/06/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Diabetes is a serious condition where the blood sugar level is too high. In spite of various awareness programs and educational camps, the number of individuals with diabetes is increasing at an alarming rate. Uncontrolled diabetes would lead to various diabetes-associated complications such as heart disease, eye disorders, kidney issues, and neurological disorders. The disease burden is not only directly from diabetes but also from various diabetes-associated conditions.
Diabetes can be self-managed to a great extent by adopting lifestyle behaviours such as diet control, physical activities, periodic doctor visits and investigations and medication adherence. These practices require the involvement of patients in self-care practices. Empowering patients with the education and awareness required to manage diabetes is very important. Traditional educational programs on diabetes management have lacked accessibility, approachability and availability. The aim of this study is to identify the impact of telephone call based diabetes education on the control of blood sugar and knowledge of diabetes.
Who can participate?
Patients with type 2 diabetes
What does the study involve?
Participants are randomly allocated to the case group or the control group. The case group receive diabetes management education through weekly phone calls for a period of 12 months. Control group participants do not receive any education. Blood sugar and knowledge of diabetes management among the groups will be compared at the start of the study and after 4, 8 and 12 months to find the impact of phone call based education.
What are the possible benefits and risks of participating?
Participants can get their HbA1C tests conducted free of cost as an incentive to participate in the study. Case group participants get diabetes management education through phone calls leading to increased knowledge of diabetes. No risks are involved in the study.
Where is the study run from?
JSS Hospital Mysore, Karnataka (India)
When is the study starting and how long is it expected to run for?
February 2016 to February 2020
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Kanakavalli K. Kundury
kanakavalli.dhsms@jssuni.edu.in
Contact information
Principal Investigator
Department of Health System Management Studies
JSS Academy of Higher Education & Research
Mysore
570004
India
 ORCID ID |
0000-0001-8479-2057 |
|---|---|
| Phone | +91 (0)9980803301 |
| kanakavalli.dhsms@jssuni.edu.in |
Study information
| Study design | Randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format |
| Scientific title | Studying the impact of providing diabetes education through phone calls on the control of hyperglycaemia and knowledge of diabetes |
| Study acronym | Madhuram |
| Study objectives | Providing continuous education through phone calls reduces HbA1C values and enhances knowledge in individuals with diabetes |
| Ethics approval(s) | Approved 30/11/2016, Institutional Ethical Committee, JSS Medical College (JSS Academy of Higher Education & Research, Sri Shivarathreeshwara Nagar, Mysore, Karnataka, 570015, India; +91 (0)821 2548337, 2548338; jssmc09@gmail.com), ref: JSSMC/11/5976/2016-17 |
| Health condition(s) or problem(s) studied | Type 2 diabetes |
| Intervention | The study is conducted at a tertiary care teaching hospital for 12 months duration. Individuals with diabetes are recruited into the study with informed consent. The participants were randomly allocated to case and control groups using a random sampling method. The participants in the case group receive continuous diabetes education through phone calls. The educational intervention on diabetes includes disease awareness, diabetes management practices, diet control, medication adherence, the role of physical activity, periodic doctor visits, investigations and monitoring for diabetes-associated comorbid conditions. Orientation/re-orientation camps are conducted once every 4 months and weekly phone calls are made to study subjects in the case group. The control group participants receive no education. HbA1C investigations are conducted in both case and control groups four times during the study period. HbA1C values and knowledge among the case and control group participants are compared to assess the impact of the telephone call based educational intervention. |
| Intervention type | Behavioural |
| Primary outcome measure | HbA1C values measured using ion exchange chromatography at baseline, 4, 8 and 12 months |
| Secondary outcome measures | Knowledge of diabetes management measured using a questionnaire at baseline, 4, 8 and 12 months |
| Overall study start date | 01/02/2016 |
| Completion date | 28/02/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Both |
| Target number of participants | 455 |
| Total final enrolment | 273 |
| Key inclusion criteria | 1. Patients with type 2 diabetes 2. Having no complex disease conditions like cardiovascular diseases (CVDs), terminally ill conditions with cancer and AIDS 3. Participants should have a reasonable ability to operate mobile phones and speak in the local language or English 4. Able to give consent to participate in the study |
| Key exclusion criteria | Does not meet the inclusion criteria |
| Date of first enrolment | 01/01/2019 |
| Date of final enrolment | 12/02/2019 |
Locations
Countries of recruitment
- India
Study participating centre
Mysore
570004
India
Sponsor information
University/education
JSS Academy of Higher Education & Research
Mysore
5700015
India
| Phone | +91 (0)821 2548337, 2548338 |
|---|---|
| jssmc09@gmail.com | |
| Website | https://jssuni.edu.in/JSSWeb/WebHome.aspx |
"ROR" |
https://ror.org/02xf0fd83 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 30/05/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Publication in a scientific journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Kanakavalli K. Kundury (kanakavalli.dhsms@jssuni.edu.in). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 10/02/2023 | 12/06/2023 | Yes | No |
Editorial Notes
12/06/2023: Publication reference added.
24/03/2022: Trial's existence confirmed by the institutional Ethical Committee, JSS Medical College.
