MultimorbidityNCT04955600
Digital Technology in the Home of Elderly Patients With Multimorbidity
An observational study of Multimorbidity, run by Sormland County Council, Sweden at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multimorbidity
- What is being tested?
- Implementation Study
- How many people
- 25 participants
- Where
- 1 siteSweden
- Study dates
- 1 Mar 2021to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study aims to include all patients, family members and healthcare personal who is involved in the process of implementation of digital technology.
Who may be able to join
- All patients admitted in the care team and their family members who will have digital technology placed in their home will be asked to participate.
- All healthcare personal in the care team will be asked to participate
Who cannot join
- 0
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Introducing Technology in the Home of Elderly Patients With Multimorbidity, a Hybrid Effectiveness Implementation Study
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.
Read the detailed 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:
- To describe the implementation process of digital technology in two different care settings from both patients, family members, and healthcare professional's perspective.
- 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.
- To examine the effectiveness of the technology.
Specific research questions the study is set to answer:
- 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?
- 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?
- How do physicians, nurses and assistant nurses experience the use of remote monitoring in their daily work?
- Which are the barriers to and facilitators for implementation of digital technology?
- 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.
- Conditions
- Multimorbidity
- Being tested
- Implementation Study
- Keywords
- telemonitoring, distance monitoring, feasibility, implementation, elderly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation StudyOther
Implementation of digital technology in two different care settings from both patients, informal caregivers, and healthcare professional's perspective.
| Study group | Role | What they receive |
|---|---|---|
| elderly patients with multimorbidity, relatives, health care personal | The care team consists of four nurses, two of whom are employed by the region and two by the municipality, 20 municipally employed assistant nurses and one physician. Other professions associated with the team are psychologist, dietitian, pharmacist, counsellor, physiotherapist, occupational therapist, and family consultants. All participants in the team will be invited to participate in the study. The technology will be place in 20-25 patients' home and patients and family members will be invited to participate in the study. Self-care education will be given to the patients and family members according to the middle-range theory of self-care of chronic illness. Receives: Other: Implementation Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of digital technology
Healthcare consumption will be performed via regions healthcare database.
Measured: December 2021-December 2022
Implementation process
Healthcare professionals will be asked about potential barriers and facilitators for implementation of the technology, problems associated with the implementation, potential modifications that could be made to maximize implementation, potential implementation strategies, skills or training necessary for healthcare professionals to work with the technology.
Measured: April 2021-December 2021
Secondary outcomes (5)
Experience of digital technology
Experience of the technology will be measured by a self-designed survey. Care and nursing staff from both the region and the municipality will is asked to answer a self-constructed questionnaire regarding experiences of the implementation of digital technology,
Measured: December 2021-December 2022
Anxiety and depression
In-depth surveys for patients; Hospital Anxiety and Depression Scale
Measured: December 2021-December 2022
Perceived control
Control Attitude Scale
Measured: December 2021-December 2022
Well-being
WHO Welfare Index
Measured: December 2021-December 2022
Physical activity
Frändin Grimby's activity scale
Measured: December 2021-December 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2021
- Study start1 Mar 2021
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MultimorbidityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sormland County Council, Sweden
- Sponsor type
- University, hospital or other
- Collaborators
- Swedish Association of Local Authorities and Regions
- Responsible party
- Principal investigator, Maria Liljeroos, Sormland County Council, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04955600
- Sponsor's protocol ID
- Maria Liljeroos
- Status last verified
- Apr 2024
- First submitted
- 16 Jun 2021
- Last updated
- 4 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liljeroos M, Akerberg A, Arkkukangas M. Older Adults and Healthcare Professional's Experiences of Telemonitoring in Primary Home-Based Care in Sweden: A Feasibility Study. Clin Interv Aging. 2026 Apr 25;21:595091. doi: 10.2147/CIA.S595091. eCollection 2026.
PubMed 42064100Liljeroos M, Arkkukangas M, Stromberg A. The long-term effect of an m-health tool on self-care in patients with heart failure: a pre-post interventional study with a mixed-method analysis. Eur J Cardiovasc Nurs. 2024 Jul 19;23(5):470-477. doi: 10.1093/eurjcn/zvad107.
PubMed 38165027
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Introducing Technology in the Home of Elderly Patients With Multimorbidity, a Hybrid Effectiveness Implementation Study
- ClinicalTrials.gov ID
- NCT04955600
- Acronym / sponsor ID
- Maria Liljeroos
- Conditions
- Multimorbidity
- Keywords
- telemonitoring, distance monitoring, feasibility, implementation, elderly
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Sormland County Council, SwedenUniversity, hospital or other
- Collaborators
- Swedish Association of Local Authorities and Regions
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 9 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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:
- To describe the implementation process of digital technology in two different care settings from both patients, family members, and healthcare professional's perspective.
- 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.
- To examine the effectiveness of the technology.
Specific research questions the study is set to answer:
- 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?
- 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?
- How do physicians, nurses and assistant nurses experience the use of remote monitoring in their daily work?
- Which are the barriers to and facilitators for implementation of digital technology?
- 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.
Study design
- Observational model
- Family based
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| elderly patients with multimorbidity, relatives, health care personal | – | Other: Implementation StudyThe care team consists of four nurses, two of whom are employed by the region and two by the municipality, 20 municipally employed assistant nurses and one physician. Other professions associated with the team are psychologist, dietitian, pharmacist, counsellor, physiotherapist, occupational therapist, and family consultants. All participants in the team will be invited to participate in the study. The technology will be place in 20-25 patients' home and patients and family members will be invited to participate in the study. Self-care education will be given to the patients and family members according to the middle-range theory of self-care of chronic illness. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study aims to include all patients, family members and healthcare personal who is involved in the process of implementation of digital technology.
Key inclusion criteria (2 listed)
- All patients admitted in the care team and their family members who will have digital technology placed in their home will be asked to participate.
- All healthcare personal in the care team will be asked to participate
Key exclusion criteria (1 listed)
- 0
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implementation StudyImplementation of digital technology in two different care settings from both patients, informal caregivers, and healthcare professional's perspective. | Other | elderly patients with multimorbidity, relatives, health care personal |
Primary outcome
Effectiveness of digital technology
Time frame: December 2021-December 2022
Healthcare consumption will be performed via regions healthcare database.
Implementation process
Time frame: April 2021-December 2021
Healthcare professionals will be asked about potential barriers and facilitators for implementation of the technology, problems associated with the implementation, potential modifications that could be made to maximize implementation, potential implementation strategies, skills or training necessary for healthcare professionals to work with the technology.
5 secondary outcomes
Experience of digital technology
Time frame: December 2021-December 2022
Anxiety and depression
Time frame: December 2021-December 2022
Perceived control
Time frame: December 2021-December 2022
Well-being
Time frame: December 2021-December 2022
Physical activity
Time frame: December 2021-December 2022
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
- Derived from this study: PubMed 42064100Liljeroos M, Akerberg A, Arkkukangas M. Older Adults and Healthcare Professional's Experiences of Telemonitoring in Primary Home-Based Care in Sweden: A Feasibility Study. Clin Interv Aging. 2026 Apr 25;21:595091. doi: 10.2147/CIA.S595091. eCollection 2026.
- Derived from this study: PubMed 38165027Liljeroos M, Arkkukangas M, Stromberg A. The long-term effect of an m-health tool on self-care in patients with heart failure: a pre-post interventional study with a mixed-method analysis. Eur J Cardiovasc Nurs. 2024 Jul 19;23(5):470-477. doi: 10.1093/eurjcn/zvad107.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multimorbidity, run by Sormland County Council, Sweden at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of digital technology (time frame: December 2021-December 2022). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04955600, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2024.