The effectiveness of telenursing for the improvement of diabetes self-management behaviors
| ISRCTN | ISRCTN17983920 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17983920 |
- Submission date
- 19/11/2022
- Registration date
- 01/12/2022
- Last edited
- 24/06/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Diabetes mellitus (DM) is a chronic metabolic disease that is the third largest cause of death in Indonesia, which is 6.7%. Indonesia is ranked 7th in the world and 3rd in Southeast Asia with 10.8 million sufferers. The prevalence of type 2 DM is increasing to 578 million in 2030 and 700 million in 2045. DM can cause complications that decreases quality of life, requires long-term care and high maintenance costs and give rise to psychological conditions in the form of mild stress. This impact must be controlled by managing the disease better using communication technology with telenursing to improve diabetes self-management behavior. This study aims to develop telenursing to improve the diabetes self-management of patients with type 2 DM.
Who can participate?
Patients aged 40-60 years old with type 2 DM who attend the endocrinology department in Panti Rapih hospital, Indonesia
What does the study involve?
Participants will be screened according to the inclusion criteria and randomly given an assignment to the control or intervention groups, they will not know which. The intervention group will be given education using telenursing and followed up using video calls every two weeks until 12 weeks. The control group will receive usual care with health education using leaflets, every month until three months. Participants in both the control and intervention groups will be measured at the baseline and week 12 for their level of knowledge, social and internal motivation, self-efficacy, and self-management of diabetes. In addition, participants will be measured for their level of knowledge and motivation in weeks 4 and 8, and self-efficacy and self-management in weeks 6.
What are the possible benefits and risks of participating?
The benefits for participants include learning about diabetes management from nurses and gaining motivation to change their health behavior, and also the ease of access to information by telenursing. A risk for participants is the use of their time while they partake in the intervention.
Where is the study run from?
Panti Rapih hospital (Indonesia)
When is the study starting and how long is it expected to run for?
September 2021 to May 2023
Who is funding the study?
Universitas Gadjah Mada (Indonesia)
Who is the main contact?
Theresia Titin Marlina, thtitin2020@mail.ugm.ac.id (Indonesia)
Contact information
Principal Investigator
Tangkil RT 6
Srihardono
Pundong
Bantul
DIY
Yogyakarta
55771
Indonesia
 ORCID ID |
0000-0002-2954-2650 |
|---|---|
| Phone | +628122788271 |
| thtitin2020@mail.ugm.ac.id |
Principal Investigator
Tangkil RT 6
Srihardono
Pundong
Bantul
DIY
Yogyakarta
55771
Indonesia
| Phone | +628122788271 |
|---|---|
| th77titin@gmail.com |
Study information
| Study design | Interventional single-blinded randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | 42793 PIS.pdf |
| Scientific title | Telenursing patients with type 2 diabetes mellitus for the improvement of diabetes self-management behaviors compared with usual care |
| Study objectives | Using telenursing can improve diabetes self-management compared to usual care |
| Ethics approval(s) | Approved 21/03/2022, Medical and Health Research Ethics Committee (MHREC) (Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada-Dr Sardjito General Hospital, Indonesia; +62 811-2666-869; mhrec_fmugm@ugm.ac.id), Ref. KE/FK/0304/EC/2022 |
| Health condition(s) or problem(s) studied | Diabetes self-management behavior |
| Intervention | The trial methodology is an interventional, single-blind, randomized, controlled trial. Researchers will screen patients according to the inclusion criteria. The researchers will then randomly assign 134 respondents to the study using a lottery. The 134 respondents will be randomized into groups using envelopes, including 67 patients in the intervention group and 67 in the control group. The participants will be blinded to which group they are in. The intervention group will receive health education through website-based telenursing and provide motivation and follow-up using video calls every two weeks until 12 weeks. The control group will receive usual care with health education using leaflets, every month until three months. The researcher will give information and motivation via telephone for approximately 15 minutes. The researcher will call the patients every two weeks. If they don't connect up to 3 times, they are declared disqualified. Participants in both the control and intervention groups will be measured at the baseline and week 12 for their level of knowledge, social and internal motivation, self-efficacy, and self-management of diabetes. In addition, participants will be measured for their level of knowledge and motivation in weeks 4 and 8, and self-efficacy and self-management in weeks 6. |
| Intervention type | Behavioural |
| Primary outcome measure | Diabetes self-management behaviors measured during video calls using the Summary Diabetes Self-Care Activities questionnaire (SDSCA) at baseline and weeks 6, and 12 |
| Secondary outcome measures | 1. Level of knowledge measured during video calls using a Diabetes Knowledge Questionnaire at baseline and weeks 4, 8 and 12 2. Motivation measured using a Diabetes Fatalism Scale and MOS_Social Support Survey at baseline and weeks 4, 8 and 12 3. Self-efficacy measured using a Diabetes Mellitus Self Efficacy Scale at baseline and weeks 6 and 12 |
| Overall study start date | 13/09/2021 |
| Completion date | 05/05/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Participants according to the inclusion criteria were 194. Target number of 134 participants, divided between the intervention and control groups (67 participants each group) |
| Total final enrolment | 134 |
| Key inclusion criteria | 1. Patients diagnosed with type 2 diabetes mellitus examined at the endocrine clinic 2. Aged 40-60 years old 3. Patients have HbA1C levels of at least 6.5% in the last three months 4. The patient has an Android phone and has installed a website browser and WhatsApp 5. Able to open a website browser and use WhatsApp 6. Willing to be a respondent |
| Key exclusion criteria | 1. Anemia (Hb ≤ 11 gr/dl) based on the doctor's diagnosis and has no history of blood transfusions in the last 2-3 months because it affects HbA1C levels 2. Impaired kidney function based on the doctor's diagnosis because it will affect hemoglobin levels and affect dietary information in the management of diabetes 3. Experiencing heart problems 4. Depression, dementia, and cognitive impairment based on the doctor's diagnosis because it can affect the patient's self-management ability |
| Date of first enrolment | 03/12/2022 |
| Date of final enrolment | 01/02/2023 |
Locations
Countries of recruitment
- Indonesia
Study participating centre
Yogyakarta
55223
Indonesia
Sponsor information
University/education
Jl. Farmako
Sekip Utara
Yogyakarta
55281
Indonesia
| Phone | +62 274 560300 |
|---|---|
| s3fk@ugm.ac.id | |
| Website | https://fkkmk.ugm.ac.id/ |
"ROR" |
https://ror.org/03ke6d638 |
Funders
Funder type
University/education
Private sector organisation / Universities (academic only)
- Alternative name(s)
- Gadjah Mada University, UGM
- Location
- Indonesia
Results and Publications
| Intention to publish date | 31/03/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated and/or analyzed during the current study will be published as a supplement to the results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 28/11/2022 | No | Yes |
Additional files
Editorial Notes
24/06/2024: The overall trial end date was changed from 20/09/2024 to 31/03/2025.
19/09/2023: The following changes were made:
1. The overall trial end date was changed from 01/05/2023 to 05/05/2023.
2. The intention to publish was changed from 20/09/2023 to 20/09/2024.
07/02/2023: The following changes were made:
1. The recruitment end date was changed from 20/05/2023 to 01/02/2023.
2. The overall trial end date was changed from 20/03/2023 to 01/05/2023.
3. Total final enrolment added.
07/12/2022: The recruitment start date was changed from 21/12/2022 to 03/12/2022.
28/11/2022: Trial's existence confirmed by Medical and Health Research Ethics Committee of the Universitas Gadjah Mada-Dr Sardjito General Hospital, Indonesia.
