To provide high-quality remote care to patients with type 2 diabetes, using an eHealth platform with support from a medical service center. The present study is optimisation and implementation research. Notably, the aim is not implementation but…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary and secondary study parameters/outcome of the study are:
• To provide a reliable and easy-to-use platform for remote care,
including the use of a medical service center with high accessibility,
usability,
acceptance and satisfaction of users.
• To maintain stable regulation: HbA1c, blood pressure, and body weight.
• To maintain adequate: health-related quality of life (PAID-5),
patient activation (PAM-6), patient satisfaction.
Secondary outcome
see above
Background summary
In times of the COVID-19 pandemic, hospital visits have been drastically
reduced to prevent infections and focus on COVID-19 care. As a result, the
number of visits to care providers decreased by 70%, and fewer patients visited
the hospitals because of non-COVID emergency conditions (such as acute
myocardial infarction). Notably, mortality increased independently of COVID-19
related complications: the loss of healthy life years due to not delivered care
for non-COVID problems was estimated in the range of 100.000-400.000 in the
first half of 2020 in the Netherlands.
Remote monitoring by telephone and video calling has become a standard
approach: no less than 90% of the appointments at outpatient clinics took place
in this way during the first worse period of this crisis. However, this
alternative approach is laborious and results in incomplete monitoring of
patients. As a result, digital applications to improve the quality of remote
care have gained importance.
The multidisciplinary care for type 2 diabetes is well-described in guidelines
and consists of the following pillars: improving lifestyle including support
for smoking cessation, carefully prescribed glucose-lowering drugs to avoid
hypoglycaemia while reducing hyperglycaemic periods, antihypertensives, and
cholesterol-lowering medication. Regular monitoring takes place of HbA1c, blood
pressure, body weight, albumin excretion in the urine, fundoscopy, vibration
and monofilament sense, an inspection of the feet, cardiovascular signs and
symptoms. Moreover, self-management is safe and successfully prevents
cardiovascular disease and other complications, not with superior but with
similar efficacy as usual care.
Therefore, telemedicine would be an appropriate approach to keep patients and
care providers connected; and deliver high-quality remote care, reducing the
collateral damage of COVID-19.
We expect that diabetes care, according to the guidelines, can be supported by
eHealth. New SkyCare is a novel eHealth platform that will implement existing
eHealth devices and connect patients and health care providers. This new
platform perfectly matches the currently changing situation of non-COVID care.
It offers a secure way to monitor patients with type 2 diabetes at home for a
long time without creating noise for the care providers. The latter will be
accomplished by algorithms based on the first steps of the guidelines and by
the support of a medical service center. The treating physicians supervise this
service center. It gives opportunities to scale up to large patients* groups
and other conditions in the short term.
The purpose of the present project is the improvement and implementation of the
diabetes platform of New SkyCare in all lines of care. Successful
implementation will improve the technology readiness level of New SkyCare,
making it ready for future efficacy studies.
Study objective
To provide high-quality remote care to patients with type 2 diabetes, using an
eHealth platform with support from a medical service center.
The present study is optimisation and implementation research. Notably, the aim
is not implementation but implementation research on usability and feasibility
of the system. If successful, the optimised version can be used for future
randomised clinical assessment of safety and efficacy.
We introduce historical controls to get a first impression about the system's
performance and enable power calculations for future research.
Study design
PDSA guided improvement and implementation research.
Study burden and risks
The burden of using New SkyCare will be assessed in the improvement PDSA cycles
and with the patient satisfaction questionnaire.
The overall risk of using this eHealth platform will be negligible, as the
target population consists of stable patients with type 2 diabetes and the
monitoring of the participants will be more frequent than in the current usual
care: the automated medical decisions are all supervised by physicians.
Measurements exceeding the thresholds will be triaged on severity by an
automated system and evaluated by the medical service center staff. Severe
deviations from the thresholds will result in an alarm to the 24/7 medical
service center, mildly abnormal values will be evaluated daily during office
hours. The medical service center receives supervision from an internist of the
research team. A medical doctor is on call day and night.
Severe deviations from the protocol will be handled as an emergency, and the
participants will be advised to visit the local Urgent Care Centre or A&E
Department.
Increased medicalisation of the participants may result in health risks.
However, self-management has been shown to be safe. Our follow-up is probably
too short to expect more adverse effects based on increased medicalisation than
in the cited study. Therefore, we estimate this risk as very low, but we will
attempt to identify negative effects based on close monitoring and increased
consumption of care after the improvement and implementation.
Similarly, some minor risk is involved in the frequent measurement of the body
weight, as more frequent weighing than weekly has been related to a negative
mood, reduced self-esteem and body dissatisfaction. We, therefore, advise
participants to measure body weight only twice a month.
Dr. Molewaterplein 40
Rotterdam 3015GD
NL
Dr. Molewaterplein 40
Rotterdam 3015GD
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
• Type 2 diabetes;
• Stable chronic disease three months prior to inclusion;
• Treated with diet and lifestyle, oral anti-diabetic medication, and/or
subcutaneous anti-diabetic medication, including insulin;
• Owns a smartphone (Android 7 or newer; IOS 11 or newer) and
o is able to use apps in Dutch;
o is able to receive push notifications;
o is able to use Bluetooth Low Energy;
o has access to a Wi-Fi connection at home.
• Able to understand and decide on written informed consent in Dutch;
• Able to perform activities of daily living (ADL) independently.
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
• Treatment with subcutaneous insulin pump;
• Female subject who is pregnant or breastfeeding or planning to become
pregnant or breastfeed during the study;
• Other types of diabetes mellitus;
• Major health conditions:
o liver, heart or lung transplant;
o untreated cancer, current chemotherapy or radiotherapy;
o acute infections, sepsis, or acute organ failure;
o cystic fibrosis;
o life expectancy less than one year;
• Alcohol or other drug abuse or psychosis in the year prior to the study;
• History of bariatric surgery.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| CCMO | NL78060.078.21 |