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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05837728
Other study ID # 320622
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 1, 2023
Est. completion date December 31, 2026

Study information

Verified date May 2023
Source University of Stavanger
Contact Marianne Storm, PhD
Phone 48133750
Email marianne.storm@uis.no
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 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?


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date December 31, 2026
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 75 Years to 105 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - <75 years, cognitive impairment, in need of palliative services

Study Design


Intervention

Behavioral:
Health 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.

Locations

Country Name City State
Norway Stavanger kommune Stavanger Rogaland

Sponsors (2)

Lead Sponsor Collaborator
University of Stavanger Stavanger Municipality, Norway

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Baseline and 5 Months
Primary 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.
Baseline and 5 Months
Primary 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.
Baseline and 5 Months
Primary 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. Baseline and 5 Months
Primary 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 Baseline and 5 Months
Primary 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. Baseline and 5 Months
Primary 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. Baseline and 5 Months
Primary 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. Baseline and 5 Months
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