Frail Elderly SyndromeNCT03180606
Enhanced Primary Care for Elderly
An observational study of Frail Elderly Syndrome, run by Region Östergötland at 2 sites in Sweden.
Trial summary
The present health care situation for the elderly in many countries is insufficient and not designed according to the health care needs of the aged population. In a pragmatic multicenter primary care setting (n= 1600), the investigators use an evidence based prediction model to find elderly (75+) with high risk for… Read more about this study
- Who is it for?
- Ages 75 to 110 years
- Conditions the study is for
- Frail Elderly Syndrome
- What is being tested?
- Multi-disciplinary and personalized primary care
- How many people
- 1,304 participants
- Where
- 2 sitesSweden
- Study dates
- 27 Sep 2017to 31 Dec 2019
- 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 75 to 110 years
- All sexes
- Older adult
Study population: People 75 years and older in the county of Östergötland with a high risk of being fragile and in need of hospital care. This risk group of 1600 out of 24000 is detected by a digital/statistical method depending on previous health care consumption and specific diagnoses
Who may be able to join
- Age 75 years and older living in county of Östergötland
Who cannot join
- No exclusion criteria
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Region Östergötland/Linköping University
Linköping, Östergötland County, 58183
Primary Care of Östergötland
Linköping, Östergötland County, 58185
About this study
Official title: Enhanced Primary Care for Elderly: A Multicenter Pragmatic Clinical Trial Where Older People With Great Needs Are Predicted and Given Personalized Primary Care
The present health care situation for the elderly in many countries is insufficient and not designed according to the health care needs of the aged population. In a pragmatic multicenter primary care setting (n= 1600), the investigators use an evidence based prediction model to find elderly (75+) with high risk for complex medical care or hospitalization and apply a differentiated and directed medical and social care to this risk group, in comparison to usual care. The intervention will include all the latest evidence based tools in the care of elderly (multi-professional team, social support, medical care home-visits, telephone support, general practitioner visits, etc). The project has high potential impact on the development of future care of elderly.
In addition to the intervention study, several academic sub-studies focusing on patient's perspective, professional roles, equality, implementation and governance management of health care will be performed.
Read the detailed description
The current project is a multidisciplinary research project covering several aspects of a shift in elderly care, with outcome measures not only related to primary medical or functional measures. The analyses will widen the view to overall societal costs and effects of changes in key institutions of social security as well as to hidden mechanisms in the governance system of care and health care of elderly.
The primary aim of the present study is to investigate the extent to which a differentiated (personalized) and targeted primary care intervention provided to a statistically predicted risk population of elderly, results in care that is more effective and of higher quality than that of a control group receiving standard care. In a pragmatic multicenter primary care setting (n= 1600), an evidence based prediction model to find elderly (75+) with high risk for complex medical care or hospitalization is used followed by a differentiated and directed medical and social care to this risk group, in comparison to usual care. The intervention will include all the latest evidence based tools in the care of elderly (multi-professional team, social support, medical care home-visits, telephone support, general practitioner visits, etc).
The investigators also aim to study the care model in a broader sense; experiences of the elderly, their social networks and diversity. Finally, the project will also investigate how the health care system, from specific health care professionals (primary care nurses, doctors, para-medical staff) to management levels and politicians influence the implementation of the present and future care models. One specific subproject focuses on the mechanisms behind the inability of steak holders/politicians and top administrative executives to find efficient governance principals for elderly care and health care, despite already available knowledge sources.
- Conditions
- Frail Elderly Syndrome
- Being tested
- Multi-disciplinary and personalized primary care
- Keywords
- Elderly, Frail, Primary care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-disciplinary and personalized primary careOther
Team-based primary care where nurse, GP, social-worker, physiotherapist, occupational therapist evaluate and give treatment
| Study group | Role | What they receive |
|---|---|---|
| Predicted and personalized primary care | Elderly 75 years of age and older in primary care with high risk of being fragile and future risk of needing hospital care that receives personalized primary care Receives: Other: Multi-disciplinary and personalized primary care | |
| Predicted but with treatment as usual | Elderly 75 years of age and older in primary care with high risk of being fragile and future risk of needing hospital care that receives treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital care days
The number of days in hospital
Measured: January 1st 2018 - December 31st 2019
Secondary outcomes (4)
Hospital care occasions
Number of occasions in hospital care
Measured: January 1st 2018 - December 31st 2019
Health related quality of life
Measured as EQ-5D scores
Measured: January 1st 2018 - December 31st 2019
Costs for health care
The total costs for health care measured in USD
Measured: January 1st 2018 - December 31st 2019
Mortality
Number of deaths during the study period
Measured: January 1st 2018 - December 31st 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2017
- Study start27 Sep 2017
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Frail Elderly SyndromeStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,304 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Östergötland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jan Marcusson, Region Östergötland
- Investigators
- Jan Marcusson, MD, PhD, Principal investigator, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03180606
- Sponsor's protocol ID
- Elderly care 2016-347-31
- Status last verified
- Jun 2020
- First submitted
- 31 May 2017
- Last updated
- 5 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Marcusson J, Nord M, Johansson MM, Alwin J, Levin LA, Dannapfel P, Thomas K, Poksinska B, Sverker A, Olaison A, Cedersund E, Kelfve S, Motel-Klingebiel A, Hellstrom I, Kullberg A, Bottiger Y, Dong HJ, Peolsson A, Wass M, Lyth J, Andersson A. Proactive healthcare for frail elderly persons: study protocol for a prospective controlled primary care intervention in Sweden. BMJ Open. 2019 May 22;9(5):e027847. doi: 10.1136/bmjopen-2018-027847.
PubMed 31122995Hansen K, Lyth J, Segernas A, Alwin J, Nord M. Self-rated health as a predictor of mortality and healthcare use in older adults at high risk of hospitalisation: a prospective cohort study in Sweden. BMJ Open. 2025 Sep 1;15(9):e091787. doi: 10.1136/bmjopen-2024-091787.
PubMed 40889980Dong HJ, Yang J, Johansson MM, Peolsson A, Barbero M, Nord M. Association between frailty and pain in older people at high risk of future hospitalization. Front Pain Res (Lausanne). 2025 Apr 28;6:1576691. doi: 10.3389/fpain.2025.1576691. eCollection 2025.
PubMed 40386744Dong HJ, Peolsson A, Johansson MM. Effects of proactive healthcare on pain, physical and activities of daily living functioning in vulnerable older adults with chronic pain: a pragmatic clinical trial with one- and two-year follow-up. Eur Geriatr Med. 2024 Jun;15(3):709-718. doi: 10.1007/s41999-024-00952-9. Epub 2024 Mar 6.
PubMed 38446408Lundgren M, Segernas A, Nord M, Alwin J, Lyth J. Reasons for hospitalisation and cumulative mortality in people, 75 years or older, at high risk of hospital admission: a prospective study. BMC Geriatr. 2024 Feb 20;24(1):176. doi: 10.1186/s12877-024-04771-2.
PubMed 38378482Kammerlind AS, Peolsson A, Johansson MM. Dizziness in older persons at high risk of future hospitalization: prevalence, differences between those with and without dizziness, and effect of a proactive primary care intervention. BMC Geriatr. 2022 Apr 10;22(1):315. doi: 10.1186/s12877-022-02910-1.
PubMed 35399055Nord M, Lyth J, Alwin J, Marcusson J. Costs and effects of comprehensive geriatric assessment in primary care for older adults with high risk for hospitalisation. BMC Geriatr. 2021 Apr 21;21(1):263. doi: 10.1186/s12877-021-02166-1.
PubMed 33882862
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Primary Care for Elderly: A Multicenter Pragmatic Clinical Trial Where Older People With Great Needs Are Predicted and Given Personalized Primary Care
- ClinicalTrials.gov ID
- NCT03180606
- Acronym / sponsor ID
- Elderly care 2016-347-31
- Conditions
- Frail Elderly Syndrome
- Keywords
- Elderly, Frail, Primary care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,304 participants (actual)
- Lead sponsor
- Region ÖstergötlandUniversity, hospital or other
- Study start
- 27 Sep 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 8 Jun 2017 (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.
The present health care situation for the elderly in many countries is insufficient and not designed according to the health care needs of the aged population. In a pragmatic multicenter primary care setting (n= 1600), the investigators use an evidence based prediction model to find elderly (75+) with high risk for complex medical care or hospitalization and apply a differentiated and directed medical and social care to this risk group, in comparison to usual care. The intervention will include all the latest evidence based tools in the care of elderly (multi-professional team, social support, medical care home-visits, telephone support, general practitioner visits, etc). The project has high potential impact on the development of future care of elderly.
In addition to the intervention study, several academic sub-studies focusing on patient's perspective, professional roles, equality, implementation and governance management of health care will be performed.
Detailed description
The current project is a multidisciplinary research project covering several aspects of a shift in elderly care, with outcome measures not only related to primary medical or functional measures. The analyses will widen the view to overall societal costs and effects of changes in key institutions of social security as well as to hidden mechanisms in the governance system of care and health care of elderly.
The primary aim of the present study is to investigate the extent to which a differentiated (personalized) and targeted primary care intervention provided to a statistically predicted risk population of elderly, results in care that is more effective and of higher quality than that of a control group receiving standard care. In a pragmatic multicenter primary care setting (n= 1600), an evidence based prediction model to find elderly (75+) with high risk for complex medical care or hospitalization is used followed by a differentiated and directed medical and social care to this risk group, in comparison to usual care. The intervention will include all the latest evidence based tools in the care of elderly (multi-professional team, social support, medical care home-visits, telephone support, general practitioner visits, etc).
The investigators also aim to study the care model in a broader sense; experiences of the elderly, their social networks and diversity. Finally, the project will also investigate how the health care system, from specific health care professionals (primary care nurses, doctors, para-medical staff) to management levels and politicians influence the implementation of the present and future care models. One specific subproject focuses on the mechanisms behind the inability of steak holders/politicians and top administrative executives to find efficient governance principals for elderly care and health care, despite already available knowledge sources.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Predicted and personalized primary care | – | Other: Multi-disciplinary and personalized primary careElderly 75 years of age and older in primary care with high risk of being fragile and future risk of needing hospital care that receives personalized primary care |
| Predicted but with treatment as usual | – | –Elderly 75 years of age and older in primary care with high risk of being fragile and future risk of needing hospital care that receives treatment as usual |
Who may qualify
- Ages
- 75 to 110 years
- Sex
- All
- Age groups
- Older adult
- Study population
- People 75 years and older in the county of Östergötland with a high risk of being fragile and in need of hospital care. This risk group of 1600 out of 24000 is detected by a digital/statistical method depending on previous health care consumption and specific diagnoses
Key inclusion criteria (1 listed)
- Age 75 years and older living in county of Östergötland
Key exclusion criteria (1 listed)
- No exclusion criteria
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 |
|---|---|---|
| Multi-disciplinary and personalized primary careTeam-based primary care where nurse, GP, social-worker, physiotherapist, occupational therapist evaluate and give treatment | Other | Predicted and personalized primary care |
Primary outcome
Hospital care days
Time frame: January 1st 2018 - December 31st 2019
The number of days in hospital
4 secondary outcomes
Hospital care occasions
Time frame: January 1st 2018 - December 31st 2019
Health related quality of life
Time frame: January 1st 2018 - December 31st 2019
Costs for health care
Time frame: January 1st 2018 - December 31st 2019
Mortality
Time frame: January 1st 2018 - December 31st 2019
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 5 Jun 2020.
- Background: PubMed 31122995Marcusson J, Nord M, Johansson MM, Alwin J, Levin LA, Dannapfel P, Thomas K, Poksinska B, Sverker A, Olaison A, Cedersund E, Kelfve S, Motel-Klingebiel A, Hellstrom I, Kullberg A, Bottiger Y, Dong HJ, Peolsson A, Wass M, Lyth J, Andersson A. Proactive healthcare for frail elderly persons: study protocol for a prospective controlled primary care intervention in Sweden. BMJ Open. 2019 May 22;9(5):e027847. doi: 10.1136/bmjopen-2018-027847.
- Derived from this study: PubMed 40889980Hansen K, Lyth J, Segernas A, Alwin J, Nord M. Self-rated health as a predictor of mortality and healthcare use in older adults at high risk of hospitalisation: a prospective cohort study in Sweden. BMJ Open. 2025 Sep 1;15(9):e091787. doi: 10.1136/bmjopen-2024-091787.
- Derived from this study: PubMed 40386744Dong HJ, Yang J, Johansson MM, Peolsson A, Barbero M, Nord M. Association between frailty and pain in older people at high risk of future hospitalization. Front Pain Res (Lausanne). 2025 Apr 28;6:1576691. doi: 10.3389/fpain.2025.1576691. eCollection 2025.
- Derived from this study: PubMed 38446408Dong HJ, Peolsson A, Johansson MM. Effects of proactive healthcare on pain, physical and activities of daily living functioning in vulnerable older adults with chronic pain: a pragmatic clinical trial with one- and two-year follow-up. Eur Geriatr Med. 2024 Jun;15(3):709-718. doi: 10.1007/s41999-024-00952-9. Epub 2024 Mar 6.
- Derived from this study: PubMed 38378482Lundgren M, Segernas A, Nord M, Alwin J, Lyth J. Reasons for hospitalisation and cumulative mortality in people, 75 years or older, at high risk of hospital admission: a prospective study. BMC Geriatr. 2024 Feb 20;24(1):176. doi: 10.1186/s12877-024-04771-2.
- Derived from this study: PubMed 35399055Kammerlind AS, Peolsson A, Johansson MM. Dizziness in older persons at high risk of future hospitalization: prevalence, differences between those with and without dizziness, and effect of a proactive primary care intervention. BMC Geriatr. 2022 Apr 10;22(1):315. doi: 10.1186/s12877-022-02910-1.
- Derived from this study: PubMed 33882862Nord M, Lyth J, Alwin J, Marcusson J. Costs and effects of comprehensive geriatric assessment in primary care for older adults with high risk for hospitalisation. BMC Geriatr. 2021 Apr 21;21(1):263. doi: 10.1186/s12877-021-02166-1.
- Study protocol articleLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Jan Marcusson, MD, PhD principal investigator
Linkoeping University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Frail Elderly Syndrome, run by Region Östergötland at 2 sites 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 1 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 5 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Hospital care days (time frame: January 1st 2018 - December 31st 2019). 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 NCT03180606, which also lists 7 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 5 Jun 2020.