FrailtyNCT05837728
Health Determinants in Older Adults Living At Home
An observational study of Frailty and Vision and Hearing Loss, run by University of Stavanger at 1 site in Norway.
Trial summary
The observational study will conduct interprofessional assessments by registered nurses, physiotherapists, and occupational therapists of health determinants (i.e., frailty, physical, cognitive, and sensory function, mental and social health, and alcohol use) in older adults (≥75) living at home and applying for a… Read more about this study
- Who is it for?
- Ages 75 to 105 years
- Conditions the study is for
- Frailty, Vision and Hearing Loss, Cognitive Function, Social 1
- What is being tested?
- Health promoting assessment of older adults living at home
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 40 participants
- Where
- 1 siteNorway
- Study dates
- 1 Mar 2023to 1 Dec 2024
- 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 105 years
- All sexes
- No healthy volunteers
- Older adult
Study population: Home-living older adults applying for municipal health services.
Who may be able to join
- Older adults, age ≥75, live at home, being cognitively able to give informed consent, apply for a public health and care service from the municipality, and have a service need for more than two weeks approved by the municipality
Who cannot join
- <75 years, cognitive impairment, in need of palliative services
Trial locations and contacts
1 site in 1 country.
About this study
Official title: More Good Days At Home: Advancing Health-promoting Practices in Municipal Healthcare Services for Older Recipients of Home Care
The observational study will conduct interprofessional assessments by registered nurses, physiotherapists, and occupational therapists of health determinants (i.e., frailty, physical, cognitive, and sensory function, mental and social health, and alcohol use) in older adults (≥75) living at home and applying for a municipal health service. The participants will take part in two assessments, baseline and 5 months. Based on the baseline assessment healthcare professionals will identify factors that can affect older adults' health, provide tailored information, offer measures, and link with proper health services. The aim is that older adults maintain health, function, and self-care and thus can continue aging at home. The main research question is:) How can interprofessional assessments of older adults living at home reduce the risk of impaired function, maintain health and ensure that the elderly receive tailored services?
Read the detailed description
The population of older adults is rapidly increasing worldwide and in Norway. A present and future challenge is to provide adequate health and care services to older persons. It is imperative to organize the services in a manner that is both adequate for the older persons in need of help and sustainable for health and care services and society. A way to ensure this is to facilitate and promote measures allowing older adults to age well at home. Accordingly, it is of great importance to enable older adults to engage with health determinants that influence their daily life actively. One area of importance is assessing health determinants and acting upon indications of functional decline, cognitive and sensory impairments, and frailty.
The observational study will assess how interprofessional assessments of health determinants in older adults living at home can promote health and reduce the risk of functional decline. The study participants will take part in two assessments of health determinants including frailty, physical, cognitive, and sensory function, mental and social health, and alcohol use. Based on results from the baseline assessment healthcare personnel will identify factors that can affect the older adult's health, provide tailored information to strengthen health literacy, and offer measures available in the health services in the municipality. The second assessment 5 months after baseline will reveal if tailoring measures and services have contributed to maintaining and supporting the older person's health and reduced the risk of functional decline. The aim of the project is that the elderly living at home maintains health, function, and self-care and thus can have more good days at home.
- Conditions
- Frailty, Vision and Hearing Loss, Cognitive Function, Social 1, Mental Health Issue, Social Functioning, Alcohol Use, Unspecified
- Being tested
- Health promoting assessment of older adults living at home
- Medical subject headings
- Frailty, Deaf-Blind Disorders, Social Adjustment, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health promoting assessment of older adults living at homeBehavioural
Based on the results of the first assessment of the older person's health determinants, healthcare professionals will recommend and tailor measures to the individual's needs to reduce the risk of functional decline and maintain their health while living at home.
| Study group | Role | What they receive |
|---|---|---|
| Older adults ≥75 living at home | Older adults ≥75 years living at home applying for a municipal health and care service for an estimated period of more than two weeks. Receives: Behavioral: Health promoting assessment of older adults living at home |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of Physical function
Change in the older adult's physical function will be measured with the "Short Physical Performance Battery". Values: 0-4. A higher score means better physical function.
Measured: Baseline and 5 Months
Measure of cognitive function
Change in the older adult's cognitive function will be measured with the "MiniCog" screening tool for cognitive impairment.
Values: 0-4. We use a cut-off value of <4 points which is recommended, as this may indicate a need for further investigation of cognitive status.
Measured: Baseline and 5 Months
Measure of clinical frailty
Change in frailty will be measured with the "Global Measure of frailty and fitness in elderly people".
Values: 0-9. A higher score means a high level of frailty.
Measured: Baseline and 5 Months
Measure of lonliness
Change in lonliness will be measured with "The Short UCLA Lonliness scale". Values: 0-3. A higher score means a high level of lonliness.
Measured: Baseline and 5 Months
Measure of depression
To assess change in depression in old age, we will use the 4-item Geriatric Depression Scale (GDS).Values: 0-1. A cut-off score >0 indicates depression
Measured: Baseline and 5 Months
Measure of alcohol use
For assessment of change in alcohol consumption, we will use the Alcohol Use Disorders Identification Test (AUDIT-C) 4 items. Values:0-12.The AUDIT-C is scored on a scale of 0-12 (scores of 0 reflect no alcohol use). In men, a score of 4 or more is considered positive; in women, a score of 3 or more is considered positive. Generally, the higher the AUDIT-C score, the more likely it is that the person's drinking is affecting his/her health.
Measured: Baseline and 5 Months
Measure of vision
Change in vision will be measured with a structured vision assessment tool called KROSS (a Norwegian acronym for Competence, Rehabilitation of Sight after Stroke) developed by the University of South-Eastern Norway in collaboration with the Vestre Viken Hospital Trust and stroke survivor organizations. The KROSS tool includes assessments of visual acuity, visual field, eye alignment and movements, and visual attention.
Measured: Baseline and 5 Months
Measure of hearing
Change in hearing will be measured with the Combined Serious Sensory Impairment (Kombinert Alvorlig Sansesvikt) KAS- Screen interview guide. The questions used in our study come from the hearing and verbal communication/social life subscales.
Measured: Baseline and 5 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start1 Mar 2023
- Primary completion28 Feb 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FrailtyStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Stavanger
- Sponsor type
- University, hospital or other
- Collaborators
- Stavanger Municipality, Norway
- Responsible party
- Sponsor
- Investigators
- Marianne Storm, PhD, Principal investigator, Universitetet i StavangerGrethe Eilertsen, PhD, Principal investigator, University of South-Eastern Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05837728
- Sponsor's protocol ID
- 320622
- Status last verified
- Dec 2024
- First submitted
- 20 Mar 2023
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kvalsvik F, Larsen BH, Eilertsen G, Falkenberg HK, Dalen I, Haaland S, Storm M. Health Needs Assessment in Home-Living Older Adults: Protocol for a Pre-Post Study. JMIR Res Protoc. 2024 Apr 18;13:e55192. doi: 10.2196/55192.
PubMed 38635319
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- More Good Days At Home: Advancing Health-promoting Practices in Municipal Healthcare Services for Older Recipients of Home Care
- ClinicalTrials.gov ID
- NCT05837728
- Acronym / sponsor ID
- 320622
- Conditions
- Frailty, Vision and Hearing Loss, Cognitive Function, Social 1, Mental Health Issue, Social Functioning, Alcohol Use, Unspecified
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of StavangerUniversity, hospital or other
- Collaborators
- Stavanger Municipality, Norway
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 1 May 2023 (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 observational study will conduct interprofessional assessments by registered nurses, physiotherapists, and occupational therapists of health determinants (i.e., frailty, physical, cognitive, and sensory function, mental and social health, and alcohol use) in older adults (≥75) living at home and applying for a municipal health service. The participants will take part in two assessments, baseline and 5 months. Based on the baseline assessment healthcare professionals will identify factors that can affect older adults' health, provide tailored information, offer measures, and link with proper health services. The aim is that older adults maintain health, function, and self-care and thus can continue aging at home. The main research question is:) How can interprofessional assessments of older adults living at home reduce the risk of impaired function, maintain health and ensure that the elderly receive tailored services?
Detailed description
The population of older adults is rapidly increasing worldwide and in Norway. A present and future challenge is to provide adequate health and care services to older persons. It is imperative to organize the services in a manner that is both adequate for the older persons in need of help and sustainable for health and care services and society. A way to ensure this is to facilitate and promote measures allowing older adults to age well at home. Accordingly, it is of great importance to enable older adults to engage with health determinants that influence their daily life actively. One area of importance is assessing health determinants and acting upon indications of functional decline, cognitive and sensory impairments, and frailty.
The observational study will assess how interprofessional assessments of health determinants in older adults living at home can promote health and reduce the risk of functional decline. The study participants will take part in two assessments of health determinants including frailty, physical, cognitive, and sensory function, mental and social health, and alcohol use. Based on results from the baseline assessment healthcare personnel will identify factors that can affect the older adult's health, provide tailored information to strengthen health literacy, and offer measures available in the health services in the municipality. The second assessment 5 months after baseline will reveal if tailoring measures and services have contributed to maintaining and supporting the older person's health and reduced the risk of functional decline. The aim of the project is that the elderly living at home maintains health, function, and self-care and thus can have more good days at home.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Older adults ≥75 living at home | – | Behavioral: Health promoting assessment of older adults living at homeOlder adults ≥75 years living at home applying for a municipal health and care service for an estimated period of more than two weeks. |
Who may qualify
- Ages
- 75 to 105 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Home-living older adults applying for municipal health services.
Key inclusion criteria (1 listed)
- Older adults, age ≥75, live at home, being cognitively able to give informed consent, apply for a public health and care service from the municipality, and have a service need for more than two weeks approved by the municipality
Key exclusion criteria (1 listed)
- <75 years, cognitive impairment, in need of palliative services
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 |
|---|---|---|
| Health promoting assessment of older adults living at homeBased on the results of the first assessment of the older person's health determinants, healthcare professionals will recommend and tailor measures to the individual's needs to reduce the risk of functional decline and maintain their health while living at home. | Behavioural | Older adults ≥75 living at home |
Primary outcome
Measure of Physical function
Time frame: Baseline and 5 Months
Change in the older adult's physical function will be measured with the "Short Physical Performance Battery". Values: 0-4. A higher score means better physical function.
Measure of cognitive function
Time frame: Baseline and 5 Months
Change in the older adult's cognitive function will be measured with the "MiniCog" screening tool for cognitive impairment. Values: 0-4. We use a cut-off value of <4 points which is recommended, as this may indicate a need for further investigation of cognitive status.
Measure of clinical frailty
Time frame: Baseline and 5 Months
Change in frailty will be measured with the "Global Measure of frailty and fitness in elderly people". Values: 0-9. A higher score means a high level of frailty.
Measure of lonliness
Time frame: Baseline and 5 Months
Change in lonliness will be measured with "The Short UCLA Lonliness scale". Values: 0-3. A higher score means a high level of lonliness.
Measure of depression
Time frame: Baseline and 5 Months
To assess change in depression in old age, we will use the 4-item Geriatric Depression Scale (GDS).Values: 0-1. A cut-off score >0 indicates depression
Measure of alcohol use
Time frame: Baseline and 5 Months
For assessment of change in alcohol consumption, we will use the Alcohol Use Disorders Identification Test (AUDIT-C) 4 items. Values:0-12.The AUDIT-C is scored on a scale of 0-12 (scores of 0 reflect no alcohol use). In men, a score of 4 or more is considered positive; in women, a score of 3 or more is considered positive. Generally, the higher the AUDIT-C score, the more likely it is that the person's drinking is affecting his/her health.
Measure of vision
Time frame: Baseline and 5 Months
Change in vision will be measured with a structured vision assessment tool called KROSS (a Norwegian acronym for Competence, Rehabilitation of Sight after Stroke) developed by the University of South-Eastern Norway in collaboration with the Vestre Viken Hospital Trust and stroke survivor organizations. The KROSS tool includes assessments of visual acuity, visual field, eye alignment and movements, and visual attention.
Measure of hearing
Time frame: Baseline and 5 Months
Change in hearing will be measured with the Combined Serious Sensory Impairment (Kombinert Alvorlig Sansesvikt) KAS- Screen interview guide. The questions used in our study come from the hearing and verbal communication/social life subscales.
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 12 Dec 2024.
- Derived from this study: PubMed 38635319Kvalsvik F, Larsen BH, Eilertsen G, Falkenberg HK, Dalen I, Haaland S, Storm M. Health Needs Assessment in Home-Living Older Adults: Protocol for a Pre-Post Study. JMIR Res Protoc. 2024 Apr 18;13:e55192. doi: 10.2196/55192.
- 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.
Marianne Storm, PhD principal investigator
Universitetet i Stavanger
Grethe Eilertsen, PhD principal investigator
University of South-Eastern Norway
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 Frailty and Vision and Hearing Loss, run by University of Stavanger at 1 site in Norway.
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 12 Dec 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 Norway. 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?
Measure of Physical function (time frame: Baseline and 5 Months). The study lists 8 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 NCT05837728, which also lists 1 linked publication.
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 12 Dec 2024.