NCT04229238

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 10, 2017

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

December 27, 2019

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 18, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

3.4 years

First QC Date

December 27, 2019

Last Update Submit

January 12, 2020

Conditions

Keywords

Nutritional statusPolypharmacyHome-dwellingPotentially inappropriate medication use

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (1)

Home-dwelling older adults

Older adults (70 +) receiving regular health care from the home nursing service. Setting is two rural municipalities in southern Norway.

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

Older adults (70 +) receiving regular health care from the home nurse service. Setting is two rural municipalities in southern Norway.

You may qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oslo, Institute for Health and Society, Department of General Practice

Oslo, 4050, Norway

RECRUITING

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Jørund Straand, professor

    Institute of Health and Society, University of Oslo, Norway

    STUDY CHAIR

Central Study Contacts

Jørund Straand, professor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 27, 2019

First Posted

January 18, 2020

Study Start

May 10, 2017

Primary Completion

September 30, 2020

Study Completion

September 30, 2020

Last Updated

January 18, 2020

Record last verified: 2020-01

Locations