Nutritional Status and Medication Treatment in Home-dwelling Older Adults

Malnutrition Clinical Trial

Official title:

Nutrition and Medication Management in Home-dwelling Older Adults. Study I: Nutritional Status and Medication Treatment in Home-dwelling Older Adults. A Cross-sectional Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04229238
• Other study ID #: 2017/12883-1
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Aged
• Malnutrition
• Polypharmacy

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