Blood pressure and blood glucose telemonitoring in seniors
| ISRCTN | ISRCTN31471852 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN31471852 |
| Secondary identifying numbers | ScubyTel-825432 |
- Submission date
- 20/09/2021
- Registration date
- 05/10/2021
- Last edited
- 24/10/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English Summary
Background and study aims
Arterial hypertension (high blood pressure) and diabetes are a significant burden on the general health of the population. This study will examine whether the addition of smart technology in the form of telemonitoring (i.e. disease control at a distance) improves the management of these chronic conditions. The main aim is to find out whether blood pressure (BP) and blood glucose (BG) telemonitoring is better than standard care in the BP and BG reduction. The secondary aim is to evaluate whether BP and BG telemonitoring is a feasible method for patients and healthcare workers.
Who can participate?
Patients aged 65 years or over with arterial hypertension and type 2 diabetes
What does the study involve?
Participants will be randomly allocated to the telemedicine group or the control group. Participants in the telemedicine group will receive a telemedicine package which will include a smartphone, blood pressure and blood glucose monitor. They will take their blood pressure two times weekly and blood glucose once monthly. Data will be transmitted via smartphone to the telemonitoring platform. The telemedicine centre coordinator (physician) will examine transmitted values and indicate appropriate interventions (e.g., change in treatment, referral to GP, phone consultation). The control group will receive standard care only. The researchers will also sample blood for laboratory tests in both groups at the start of the study and after 12 months.
What are the possible benefits and risks of participating?
Patients in the telemedicine group will receive a telemedicine package. Measurement of blood pressure is a non-invasive and safe procedure. Blood glucose measurement may cause minimal pain in the fingers, dizziness, or inflammation at the measurement site. No significant side effects are expected.
Where is the study run from?
The Primary Healthcare Centre Ljubljana (Slovenia)
When is the study starting and how long is it expected to run for?
January 2021 to September 2023
Who is funding the study?
EU H2020 - Health programme (H2020-SC1)
Who is the main contact?
Prof. Antonija Poplas Susič
antonija.poplas-susic@zd-lj.si
Contact information
Scientific
Metelkova ulica 9
Ljubljana
1000
Slovenia
 ORCID ID |
0000-0003-4041-8682 |
|---|---|
| Phone | +386 (0)40 520 247 |
| mihevc.matic@zd-tr.si |
Scientific
Metelkova ulica 9
Ljubljana
1000
Slovenia
| ORCID ID |
0000-0002-4328-3333 |
|---|---|
| Phone | +386 (0)1 300 39 41 |
| antonija.poplas-susic@zd-lj.si |
Study information
| Study design | Multicentre randomized controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Prevention |
| Participant information sheet | 40451_PIS.pdf |
| Scientific title | Telemonitoring of patients with comorbid hypertension and type 2 diabetes mellitus: a multicentre randomised controlled pilot study |
| Study acronym | ScubyTel |
| Study hypothesis | The goals of the study are: 1. To evaluate the effect of blood pressure (BP) and blood glucose (BG) telemonitoring (TM) on BP and BG reduction in a group of patients with comorbid arterial hypertension (AH) and type 2 diabetes mellitus (T2DM) 2. To evaluate BP and BG TM's effect on mental health (depressive and anxiety symptoms) and other behavioural risk factors (daily activity, nutrition, alcohol consumption, smoking) 3. To evaluate the effect of BP and BG TM on quality of life 4. To evaluate the acceptability of BP and BG TM for patients and healthcare workers 5. To evaluate costs associated with the intervention and perform a cost-effectiveness analysis |
| Ethics approval(s) | Approved 24/05/2019, Slovenian National Medical Ethics Committee (Komisija Republike Slovenije za medicinsko etiko, Štefanova ulica 5, SI-1000 Ljubljana, Slovenia; +386 (0)1 478 69 06; kme.mz@gov.si), ref: 0120-219/2019/4 |
| Condition | Prevention of cardiovascular disease in patients with diabetes and arterial hypertension |
| Intervention | The SCUBY telemedicine pilot study is a randomised controlled study comparing telemonitoring of blood pressure and blood glucose (intervention group) with a standard care (control group). This multicentre pilot study will run in three primary healthcare centres in Slovenia and will last for 12 months. It will include patients with hypertension and diabetes mellitus type 2 over 65 years of age who will be randomised in a 1:1 ratio to the experimental or control group. After consented to participate, patients will be randomised to either the intervention or control group. We will use a simple 1:1 randomisation. The first patient on the list will be randomised to the telemedicine group (intervention group). The second patient will be randomised to the standard care group (control group). If candidates drop out within the first week of the study, new patients will be sought. These will be randomised according to the previous randomisation list of patients. If the last patient on the list was randomised to the telemedicine group, the next patient will be randomised to the control group and vice versa. Patients in the intervention group will receive a telemedicine package (blood glucose monitor, blood pressure monitor, smartphone) and take blood pressure twice weekly and blood glucose once monthly according to the protocol. Data will be transmitted via smartphone to the telemonitoring platform, where the telemedicine centre coordinator (physician) will examine transmitted values and indicate appropriate interventions (e.g., change in protocol regimen, referral to GP, phone consultation). The control group will receive standard care only. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Not provided at time of registration |
| Primary outcome measure | 1. Systolic blood pressure measured with standardised BP monitors at baseline, 6 months, and 12 months 2. Glycated haemoglobin assessed with laboratory testing at baseline and 12 months. |
| Secondary outcome measures | 1. Diastolic blood pressure measured with standardised BP monitors at baseline, 6 months, and 12 months 2. Lipid profile assessed with laboratory testing at baseline and 12 months 3. Glomerular filtration rate assessed with laboratory testing at baseline and 12 months 4. Body mass index assessed with standardised scales at baseline and 12 months 5. Appraisal of diabetes measured with the Appraisal of Diabetes scale at baseline and 12 months 6. Depressive symptoms measured with the Patient Health Questionnaire-9 at baseline and 12 months 7. Anxiety symptoms measured with the General Anxiety Disorder-7 questionnaire at baseline and 12 months |
| Overall study start date | 01/01/2021 |
| Overall study end date | 01/09/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Lower age limit | 65 Years |
| Sex | Both |
| Target number of participants | 120 |
| Total final enrolment | 128 |
| Participant inclusion criteria | 1. ≥65 years of age 2. AH and T2DM 3. Diagnosis of AH and T2DM for at least 1 year 4. Capability of smartphone use |
| Participant exclusion criteria | 1. <65 years of age 2. T2DM on insulin treatment 3. Type 1 diabetes or gestational diabetes 4. Cognitive impairment |
| Recruitment start date | 15/03/2021 |
| Recruitment end date | 01/06/2022 |
Locations
Countries of recruitment
- Slovenia
Study participating centres
Ljubljana
1000
Slovenia
Trebnje
8210
Slovenia
Slovenj Gradec
2380
Slovenia
Sponsor information
Hospital/treatment centre
Metelkova ulica 9
Ljubljana
1000
Slovenia
| Phone | +386 (0)1 300 39 28 |
|---|---|
| taj.irroz@zd-lj.si | |
| Website | http://www.zd-lj.si/en/ |
"ROR" |
https://ror.org/04fx4vz25 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- H2020 Societal Challenges - Health, Demographic Change and Well-being, H2020 DÉFIS DE SOCIÉTÉ - Santé, évolution démographique et bien-être, H2020 GESELLSCHAFTLICHE HERAUSFORDERUNGEN - Gesundheit, demografischer Wandel und Wohlergehen, H2020 RETOS DE LA SOCIEDAD - Salud, cambio demográfico y bienestar, H2020 SFIDE PER LA SOCIETÀ - Salute, evoluzione demografica e benessere, H2020 WYZWANIA SPOŁECZNE - Zdrowie, zmiany demograficzne i dobrostan, HEALTH, SOCIETAL CHALLENGES - Health, demographic change and well-being, RETOS DE LA SOCIEDAD - Salud, cambio demográfico y bienestar, DÉFIS DE SOCIÉTÉ - Santé, évolution démographique et bien-être, SFIDE PER LA SOCIETÀ - Salute, evoluzione demografica e benessere, WYZWANIA SPOŁECZNE - Zdrowie, zmiany demograficzne i dobrostan, GESELLSCHAFTLICHE HERAUSFORDERUNGEN - Gesundheit, demografischer Wandel und Wohlergehen
Results and Publications
| Intention to publish date | 01/01/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication of the results in a high-impact peer-reviewed journal. The researchers also plan to publish a detailed clinical protocol and statistical analysis plan in a peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from the principal investigator Prof. Antonija Poplas Susič (antonija.poplas-susic@zd-lj.si) (e.g., for meta-analyses). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 22/09/2021 | No | Yes | ||
| Protocol article | 28/09/2022 | 07/03/2023 | Yes | No | |
| Statistical Analysis Plan | see section 2.13 | 28/09/2022 | 07/03/2023 | No | No |
| Dataset | 24/10/2024 | No | No | ||
| Results article | 15/05/2024 | 24/10/2024 | Yes | No | |
| Results article | 01/03/2024 | 24/10/2024 | Yes | No |
Additional files
Editorial Notes
24/10/2024: The following changes were made to the trial record:
1. The total final enrolment was changed from 120 to 128.
2. Publication reference added.
3. Link to dataset added.
16/06/2023: The following changes were made to the trial record:
1. The overall end date was changed from 01/06/2023 to 01/09/2023.
2. The total final enrolment was added.
07/03/2023: Publication reference added.
22/09/2021: Trial's existence confirmed by the Slovenian National Medical Ethics Committee.
