Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04955600 |
| Other study ID # |
Maria Liljeroos |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2021 |
| Est. completion date |
December 31, 2023 |
Study information
| Verified date |
April 2024 |
| Source |
Sormland County Council, Sweden |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
In this study, the objective is to evaluate available technology designed to support
self-care at home of elderly patients with multimorbidity. Of people who are 85 years or
older, about 60% have two or more chronic diseases. The symptom burden is extensive, and
periods of deterioration often lead to hospitalizations and early readmissions to hospital. A
contributing factor for the high consumption of care is that many patients find it difficult
to identify signs of deterioration and in time take appropriate action. Technology placed in
patients' home are becoming common and have shown to increase quality of life and reduce the
need for in-hospital care but few tools are used in regular care.
The investigators want to see which effect technologies placed at home has on; healthcare
consumption, self-care, depression, well-being and activity level. Further, the
implementation process from both patients, relatives and healthcare personals perspective
will be studied using a hybrid design, which makes it possible to study both barriers and
facilitators of the implementation and efficacy of the technology.
In phase one participants will be recruited from a care team where an established
collaboration between region and municipality has been developed. In phase two, inclusion
takes place in an entire municipality without a previously established collaboration. The
goal is to increase patients and family members wellbeing, health and functional ability
while maintaining or reducing healthcare costs.
Description:
PURPOSE AND AIMS In this study, the objective is to evaluate available digital technology
with remote symptom monitoring designed to support self-care at home of elderly patients with
multimorbidity. There are a lot of technology with the possibility to remotely monitor signs
and symptoms placed in patients' home available. This technology have been shown to increase
quality of life, experiences of security and reduce the need for in-hospital care, but few
tools are implemented in routine care of elderly with multimorbidity and extensive needs of
coordinated health and community care. Limited collaboration and lack of joint care goals
between the different care providers are known barriers of implementation of digital
technology with remote symptom monitoring.
The overall aims of the project are:
1. To describe the implementation process of digital technology in two different care
settings from both patients, family members, and healthcare professional's perspective.
2. To evaluate the feasibility of digital technology for remote symptom monitoring and
digital consultations with the caregiver in the home of elderly patients with
multimorbidity.
3. To examine the effectiveness of the technology.
Specific research questions the study is set to answer:
1. What effects does the use of digital technology for remote symptom monitoring have on
elderly patients with multimorbidity's healthcare consumption, self-care management,
depression, experience of control over the disease, well-being and activity level?
2. How do patients and informal caregivers perceive that the use of digital technology at
home affects the ability to manage the patient's health situation?
3. How do physicians, nurses and assistant nurses experience the use of remote monitoring
in their daily work?
4. Which are the barriers to and facilitators for implementation of digital technology?
5. Does digital technology reduce the risk of hospitalisation and healthcare costs in
elderly patients with multimorbidity?
The study has a hybrid design, which means a double focus: both the implementation process
and the clinical outcomes are studied simultaneously through a mixed data collection with
both quantitative and qualitative parts. The implementation process will be based on The
Quality Implementation Framework.
Phase 1; During winter 2021-22 the implementation process of digital technology with remote
symptom monitoring with adaptation and preparation in the care team will begin. The team
needs to develop a structure for handling the incoming patient data and develop action plans
on how to act in case of symptoms and signs of deterioration.
The technology, OPTILOGG PLUS, will be place in patients' home.It consists of a tablet with
personalized sensors, such as weighing scale, blood pressure, oxygenation and activity meters
based on the patient's individual needs. The technology also includes a platform for digital
consultation.
The patient performs measurements at home every morning and sends data to the receiving
station installed in the care teams' premises where the staff access the patient's data via
secure login.The main purpose of the technology is to enhance the patients' self-care
behaviour, and coach them to contact the healthcare provider if and when self-care is not
enough to prevent deterioration. Also the caregiver can initiate a virtual home visit or a
physical home visit if they observe signs of deterioration not recognised by the patient.
