ClinicalTrials.gg
CompletedNCT05837728Updated Dec 12, 2024

Health Determinants in Older Adults Living At Home

An observational study in Frailty, Vision and Hearing Loss and Cognitive Function, Social 1, sponsored by University of Stavanger. Completed at 1 site in Norway. Open to participants aged 75 Years to 105 Years. Per ClinicalTrials.gov, last updated 2024-12-12.

Sponsored by University of Stavanger · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
40
Ages
75 Years to 105 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Frailty
  • Vision and Hearing Loss
  • Cognitive Function, Social 1
  • Mental Health Issue
  • Social Functioning
  • Alcohol Use, Unspecified
  • Healthy Aging
03

In context

Frailty

1,284 studies on the registry are indexed under Frailty; 452 are open to participants now.

This study's enrollment of 40 is below the median of 225 across 493 observational studies indexed under Frailty.

Browse Frailty studies →

Lead sponsor

University of Stavanger is the lead sponsor of 7 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
75 Years to 105 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Home-living older adults applying for municipal health services.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Older adults, age ≥75, live at home, being cognitively able to give , 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

Exclusion criteria

Exclusion Criteria:

  • \<75 years, cognitive impairment, in need of palliative services
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
40 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

    Behavioral: Health promoting assessment of older adults living at home

Interventions

  • BehavioralHealth promoting assessment of older adults living at home

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline and 5 Months

  2. 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.

    Time frame: Baseline and 5 Months

  3. 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.

    Time frame: Baseline and 5 Months

  4. 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.

    Time frame: Baseline and 5 Months

  5. 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

    Time frame: Baseline and 5 Months

  6. 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.

    Time frame: Baseline and 5 Months

  7. 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.

    Time frame: Baseline and 5 Months

  8. 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.

    Time frame: Baseline and 5 Months

07

Study locations

1 site
  • Stavanger kommune
    Stavanger, Rogaland 4068, Norway
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2023 to primary completion in Feb 2024, 11 months.

Of 289 non-industry observational studies under Frailty, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 55. This study's 11 months is below that.

Counting every sponsor, half of 292 studies reached it within 29 months; a quarter within 12 and three quarters within 55.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 20, 2023
First posted
May 1, 2023
StartActual
Mar 1, 2023
Primary completionActual
Feb 28, 2024
CompletionActual
Dec 1, 2024
Last update
Dec 12, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05837728
Lead sponsor
University of Stavanger
Collaborators
Stavanger Municipality, Norway
Responsible party
Sponsor
First posted
May 1, 2023
Start date
Mar 1, 2023
Primary completion
Feb 28, 2024
Completion
Dec 1, 2024
Last update
Dec 12, 2024

Study contacts

Marianne Storm, PhD
principal investigator · Universitetet i Stavanger
Grethe Eilertsen, PhD
principal investigator · University of South-Eastern Norway

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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