Nutritional Status and Medication Treatment in Home-dwelling Older Adults

• Conditions: Malnutrition; Aged; Polypharmacy

• Registration Number: NCT04229238
• Lead Sponsor: University of Oslo

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2017-05-10
• Study First Submitted: 2019-12-27
• Status Verified: 2020-01
• Study First Submitted QC: 2020-01-12
• Last Update Submitted: 2020-01-12
• Study First Posted: 2020-01-18
• Last Update Posted: 2020-01-18
• Primary Completion: 2020-09-30
• Study Completion: 2020-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Nutritional status	week 1	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.
Potential Inappropriate medication	week 1	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.
Drugs with high risk for causing nausea, loss of appetite and dry mouth	week 1	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

Trial Locations

Locations (1)

University of Oslo, Institute for Health and Society, Department of General Practice; 🇳🇴 Oslo, Norway