FrailtyNCT06368674
Bridging the Gap: Creating a Continuum of Care
A study testing Intervention group Case Manager (CM) in people with Frailty and Dependence, run by Göteborg University at 1 site in Sweden.
Trial summary
Coordination and integration between care settings is essential for the quality of care of frail older patients. An active follow-up by a case manager (CM) after discharge form an acute geriatric hospital ward has the potential to bridge the gap between hospital, primary and municipality care for frail older people. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Frailty, Dependence, Integrated Care
- What is being tested?
- Intervention group Case Manager (CM)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSweden
- Study dates
- 6 Jun 2024to 1 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 75 years or older, screened as frail, admitted to an acute geriatric ward working according to CGA at the Sahlgrenska or Mölndal hospital. Both hospitals are part of Sahlgrenska University hospital, with the same catchment area, including Gothenburg with surrounding municipalities. People in the region can seek care at both hospitals. The orthopaedic clinic is situated at Mölndal hospital, resulting in most patients with fractures being admitted to this hospital, irrespective of in which municipality they are living. Cognitive impairment is not an exclusion criterion. For people who cannot give informed consent due to cognitive impairment, next of kin will be asked to assist with the consent.
Who cannot join
- Less that 75 years old, Not residing in a permanent residence.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
University of Gothenburg
Gothenburg
Isabelle Andersson Hammar, PhD, Associate Professor, +46766185719, Isabelle.a-h@neuro.gu.se
About this study
Official title: Bridging the Gap: Creating a Continuum of Care Through Active Follow-up by a Case Manager After Discharge - a Controlled Study
Coordination and integration between care settings is essential for the quality of care of frail older patients. An active follow-up by a case manager (CM) after discharge form an acute geriatric hospital ward has the potential to bridge the gap between hospital, primary and municipality care for frail older people. This study evaluates the effects of an active follow-up by a CM in primary care after discharge from a geriatric ward, with the following research questions: Can an active follow-up by CM for frail older people discharged from an acute geriatric ward, compared to those not receiving active follow up, Maintain/increase independence in activities of daily living, self-rated health and life satisfaction? Increase satisfaction with health care? Reduce health care consumption/be cost-effective? How feasible is the intervention and the study design from the perspective of the caregivers and the older person? This is a clinical controlled study with a process evaluation. Inclusion criteria are 75 years or older, frail and admitted to a geriatric ward.
This study is relevant since today's highly specialized acute care is poorly adapted to the comprehensive needs of frail older people, and exposes them to avoidable risks such as loss of functional capacities causing unnecessary care needs and decreased wellbeing. Active follow-up by a CM after discharge may be an important way to integrate the care for frail older people, after receiving in-hospital geriatric care. This can improve the quality of care for this vulnerable group, and direct the right health care actions towards those in most need.
The intervention is a active follow-up after discharge by a CM (nurse) in primary care. CM will secure that discharge and care plans are executed and to address new needs. If there are unmet needs, the CM will ensure that adequate actions are performed to meet the needs. The intervention group consists of participants discharged to a primary health care centre with a CM, who actively follows-up after discharge. The control group consists of participants discharged to a primary health care centre without CM, and thereby no active follow-up after discharge. All participants will be followed-up by the research team during one year, concerning dependence in activities of daily living, self-rated health, health care consumption and satisfaction with care.
- Conditions
- Frailty, Dependence, Integrated Care
- Being tested
- Intervention group Case Manager (CM), Control Group
- Keywords
- Person-centred care
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention group Case Manager (CM)Other
The CM will be informed about the discharge plan from the nurse at the geriatric ward, as will the municipality for those with need of home help care. An outline of the intervention has been created with managers from primary care and rehabilitation within primary care and municipality care. Core components in the intervention will be active follow-up of the discharge, rehabilitation and care plans. If there are plans that have not been executed or unmet needs, the CM will take adequate contacts to ensure that actions are made to meet the needs. These contacts can be, e.g. the GP for medical needs, the rehabilitation unit in primary or municipality care for unmet rehabilitation needs, and the home help service for unmet care needs. The CM will have a network of contact persons in hospital, primary and community care, as well as in rehabilitation in primary and community care, in order to facilitate for prompt actions to meet the needs.
Control GroupOther
The participants in the control group with a planned follow-up by a primary health care centre within the catchment area of the Sahlgrenska University Hospital that does not have CMs designated for active follow up of discharged frail older people. Thus, the participants in the control group will not actively be followed-up after discharge.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group Case Manager (CM) | Experimental | The intervention group will receive extra follow-up by a CM after discharge. Receives: Other: Intervention group Case Manager (CM) |
| Control group | Other | The control group will receive usual follow-up after discharge, i.e. no active follow-up Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dependency in Activities of Daily Living (ADL)
The primary outcome, dependence in activities of daily living, is measured using the ADL-staircase assessment. It measures dependence in 9 activities: cleaning, shopping, transportation, cooking, bathing, dressing, going to the toilet, transferring, and feeding.
Dependence is defined as a state in which another person is involved in the activity by giving personal or directive assistance. The sum of dependence in the nine activities of daily living will be calculated, range 0-9, with a clinical significant change of ≥1 unit between baseline and follow up.
Measured: Baseline to 12 months
Secondary outcomes (4)
Self-rated health
Measured by the question: "In general, you would say your health is", with the response alternatives: excellent, very good, good, fair, and poor. Clinically significant difference is ≥1 step in the response alternatives between baseline and follow up.
Measured: Baseline to 12 months
Life satisfaction
Measured using the Fugl-Meyer-Lisat-11questionnaire, which includes 11 items concerning satisfaction with: life as a whole, work, financial situation, leisure, friends and acquaintance, sexual life, functional capacity, family life, partner relationship, physical health, and psychological health. Response alternatives are: very dissatisfied, dissatisfied, rather dissatisfied, rather satisfied, satisfied, and very satisfied. The sum of items for which the respondent reports being satisfied will be calculated, range 0-11, with a clinically significant change of ≥1 between baseline and follow up.
Measured: Baseline to 12 months
Satisfaction with quality of care
Measured by the participants' agreement with the following statements: "I feel that the care given during the hospital stay meets my needs"; "I am satisfied with the hospital care"; "I feel that the care planning meeting before discharge was valuable"; "I was able to take part in the discussions of my needs in the care planning meeting"; "I feel that the actions planned equal my needs", "I feel that the actions delivered equal my needs"; "I feel that the follow-up after discharge by primary care/rehabilitation/ home help care meet my needs"; and "I feel that it is valuable to have a designated case manager in the primary care". The response alternatives are: agree completely, agree partly, neither agree nor disagree, disagree, and disagree completely. An answer of agree completely or agree partly will be considered as being satisfied.
Measured: Baseline to 12 months
Health economics
Health and social care consumption for 1 year following study enrolment. Health care consumption will be retrieved from the regional care databases, including in-hospital and outpatient care, visits to primary healthcare (physicians, physiotherapists, occupational therapists, nurses, and assistant nurses), and home visits by primary healthcare professionals. The number of readmissions, number of in-hospital days, time to first readmission, and number of outpatient visits will be calculated and compared between intervention and control group.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start6 Jun 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Clinical control study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Vastra Gotaland Region, Sahlgrenska University Hospital, Forte
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06368674
- Sponsor's protocol ID
- 2023-00363
- Other IDs
- 2023
- Status last verified
- Apr 2025
- First submitted
- 11 Apr 2024
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bridging the Gap: Creating a Continuum of Care Through Active Follow-up by a Case Manager After Discharge - a Controlled Study
- ClinicalTrials.gov ID
- NCT06368674
- Acronym / sponsor ID
- 2023-00363
- Conditions
- Frailty, Dependence, Integrated Care
- Keywords
- Person-centred care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Collaborators
- Vastra Gotaland Region, Sahlgrenska University Hospital, Forte
- Study start
- 6 Jun 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 16 Apr 2024 (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.
Coordination and integration between care settings is essential for the quality of care of frail older patients. An active follow-up by a case manager (CM) after discharge form an acute geriatric hospital ward has the potential to bridge the gap between hospital, primary and municipality care for frail older people. This study evaluates the effects of an active follow-up by a CM in primary care after discharge from a geriatric ward, with the following research questions: Can an active follow-up by CM for frail older people discharged from an acute geriatric ward, compared to those not receiving active follow up, Maintain/increase independence in activities of daily living, self-rated health and life satisfaction? Increase satisfaction with health care? Reduce health care consumption/be cost-effective? How feasible is the intervention and the study design from the perspective of the caregivers and the older person? This is a clinical controlled study with a process evaluation. Inclusion criteria are 75 years or older, frail and admitted to a geriatric ward.
This study is relevant since today's highly specialized acute care is poorly adapted to the comprehensive needs of frail older people, and exposes them to avoidable risks such as loss of functional capacities causing unnecessary care needs and decreased wellbeing. Active follow-up by a CM after discharge may be an important way to integrate the care for frail older people, after receiving in-hospital geriatric care. This can improve the quality of care for this vulnerable group, and direct the right health care actions towards those in most need.
The intervention is a active follow-up after discharge by a CM (nurse) in primary care. CM will secure that discharge and care plans are executed and to address new needs. If there are unmet needs, the CM will ensure that adequate actions are performed to meet the needs. The intervention group consists of participants discharged to a primary health care centre with a CM, who actively follows-up after discharge. The control group consists of participants discharged to a primary health care centre without CM, and thereby no active follow-up after discharge. All participants will be followed-up by the research team during one year, concerning dependence in activities of daily living, self-rated health, health care consumption and satisfaction with care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Clinical control study
| Arm | Type | Receives |
|---|---|---|
| Intervention group Case Manager (CM) | Experimental | Other: Intervention group Case Manager (CM)The intervention group will receive extra follow-up by a CM after discharge. |
| Control group | Other | Other: Control GroupThe control group will receive usual follow-up after discharge, i.e. no active follow-up |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- 75 years or older, screened as frail, admitted to an acute geriatric ward working according to CGA at the Sahlgrenska or Mölndal hospital. Both hospitals are part of Sahlgrenska University hospital, with the same catchment area, including Gothenburg with surrounding municipalities. People in the region can seek care at both hospitals. The orthopaedic clinic is situated at Mölndal hospital, resulting in most patients with fractures being admitted to this hospital, irrespective of in which municipality they are living. Cognitive impairment is not an exclusion criterion. For people who cannot give informed consent due to cognitive impairment, next of kin will be asked to assist with the consent.
Key exclusion criteria (1 listed)
- Less that 75 years old, Not residing in a permanent residence.
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 |
|---|---|---|
| Intervention group Case Manager (CM)The CM will be informed about the discharge plan from the nurse at the geriatric ward, as will the municipality for those with need of home help care. An outline of the intervention has been created with managers from primary care and rehabilitation within primary care and municipality care. Core components in the intervention will be active follow-up of the discharge, rehabilitation and care plans. If there are plans that have not been executed or unmet needs, the CM will take adequate contacts to ensure that actions are made to meet the needs. These contacts can be, e.g. the GP for medical needs, the rehabilitation unit in primary or municipality care for unmet rehabilitation needs, and the home help service for unmet care needs. The CM will have a network of contact persons in hospital, primary and community care, as well as in rehabilitation in primary and community care, in order to facilitate for prompt actions to meet the needs. | Other | Intervention group Case Manager (CM) |
| Control GroupThe participants in the control group with a planned follow-up by a primary health care centre within the catchment area of the Sahlgrenska University Hospital that does not have CMs designated for active follow up of discharged frail older people. Thus, the participants in the control group will not actively be followed-up after discharge. | Other | Control group |
Primary outcome
Dependency in Activities of Daily Living (ADL)
Time frame: Baseline to 12 months
The primary outcome, dependence in activities of daily living, is measured using the ADL-staircase assessment. It measures dependence in 9 activities: cleaning, shopping, transportation, cooking, bathing, dressing, going to the toilet, transferring, and feeding. Dependence is defined as a state in which another person is involved in the activity by giving personal or directive assistance. The sum of dependence in the nine activities of daily living will be calculated, range 0-9, with a clinical significant change of ≥1 unit between baseline and follow up.
4 secondary outcomes
Self-rated health
Time frame: Baseline to 12 months
Life satisfaction
Time frame: Baseline to 12 months
Satisfaction with quality of care
Time frame: Baseline to 12 months
Health economics
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention group Case Manager (CM) in people with Frailty and Dependence, run by Göteborg University 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 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: looking for participants now, as of the sponsor's last update on 11 Apr 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Theresa Westgård, PhD, Associate Professor (18628820334, Theresa.westgard@neuro.gu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dependency in Activities of Daily Living (ADL) (time frame: Baseline to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Apr 2025.