Nutritional Status and Medication Treatment in Home-dwelling Older Adults

January 12, 2020 updated by: Mari Fiske, University of Oslo

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

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 4050
        • Recruiting
        • University of Oslo, Institute for Health and Society, Department of General Practice
        • Contact:
          • Professor
        • Contact:
        • Sub-Investigator:
          • Jørund Straand, professor
        • Sub-Investigator:
          • Anne Moen, professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Home-dwelling older adults
Older adults (70 +) receiving regular health care from the home nursing service. Setting is two rural municipalities in southern Norway.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nutritional status
Time Frame: 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.
week 1
Potential Inappropriate medication
Time Frame: 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.
week 1
Drugs with high risk for causing nausea, loss of appetite and dry mouth
Time Frame: 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
week 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oslo

Collaborators

The Norwegian Research Fund for General Practice

Investigators

  • Study Chair: Jørund Straand, professor, Institute of Health and Society, University of Oslo, Norway

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 10, 2017

Primary Completion (Anticipated)

September 30, 2020

Study Completion (Anticipated)

September 30, 2020

Study Registration Dates

First Submitted

December 27, 2019

First Submitted That Met QC Criteria

January 12, 2020

First Posted (Actual)

January 18, 2020

Study Record Updates

Last Update Posted (Actual)

January 18, 2020

Last Update Submitted That Met QC Criteria

January 12, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017/12883-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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