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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04229238
Other study ID # 2017/12883-1
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 10, 2017
Est. completion date September 30, 2020

Study information

Verified date January 2020
Source University of Oslo
Contact Mari Fiske, phd
Phone 0047 92667311
Email mari.fiske@medisin.uio.no
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The project "Nutrition and Medication management in home-dwelling older adults" consist of two separate studies witch are described in the same study protocol. This is the first study in this Project. The second study is described separately; Identification: 2017/12883-2

Malnutrition is common in older adults. The causes are many and include adverse drug effects. Loss of appetite, nausea, or dry mouth are adverse drug effects, which may contribute to malnutrition. Knowledge about possible relations between drug treatment and nutritional status is scarce.

The objectives of the project is to describe nutritional status, drug treatment and the prevalence of potentially inappropriate medication in home-dwelling elderly receiving home care service in two Norwegian municipalities.


Description:

Recruitment by a the home nurse service. An informed content from the participant (or a close relative for those not able to give an informed consent) is required. A nurse will visit the participants and ask for information about six items concerning: food intake, weight loss, mobility, psychological stress, neuropsychological problems. The height and weight will be measured. A photo of the medicine prescription card will be taken. The investigators have created an online solution for collection of these sensitive data, including photos of the medication prescription card.

The data will automatically be stored in a secure database at the University of Oslo (TSD), for further analyses.


Recruitment information / eligibility

Status Recruiting
Enrollment 400
Est. completion date September 30, 2020
Est. primary completion date September 30, 2020
Accepts healthy volunteers No
Gender All
Age group 70 Years and older
Eligibility Inclusion Criteria:

- Home-dwelling

- Be admitted to home-nursing service, every second week or more often.

- Age 70 or older

- Medication administrated by home nursing service.

- Informed consent by patient or close relative (next of kin)

Exclusion Criteria:

• Patient or next of kin denies inclusion

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Norway University of Oslo, Institute for Health and Society, Department of General Practice Oslo

Sponsors (2)

Lead Sponsor Collaborator
University of Oslo The Norwegian Research Fund for General Practice

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary Nutritional status By use of Mini Nutritional Assessment Short Form (MNA-SF).Maximum value 14, minimum value 0. 0 -7 points indicates malnutrition. 8-11 points indicate risk for malnutrition. 12-14 points indicates well nourished. The higher score a better outcome. week 1
Primary Potential Inappropriate medication Prevalence of potential Inappropriate medication due the Norwegian General Practise Nursing home( NORGEP) criteria.
A: Single criteria; Regular use should be avoided. B: Combination criteria; Combinations to avoid C: Deprescribing (discontinue) criteria: Need for continued use should be reassessed: See Protocol page 19-20; Attachment 1.
week 1
Primary Drugs with high risk for causing nausea, loss of appetite and dry mouth Prevalence of drugs with high risk for causing nausea, loss of appetite and dry mouth, according to a list we have made( Nause-Appetite-Dry mouth list) see Protocol page 21-23,attachment 2 week 1
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