NCT04228900

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 second study in this Project. The first study (cross sectional) is described separately; Identification: 2017/12883-1 Undernutrition is common in older adults. The causes are many and include drug therapy. Drug side effects, as loss of appetite, nausea, or dry mouth, may contribute to malnutrition, impaired health and loss of function. In patients with malnutrition or at risk for malnutrition we will evaluate an intervention consisting of:

  • an "individual nutritional plan" with different measures aiming at improving nutritional status.
  • a systematic drug review.

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
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2020

Typical duration for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 27, 2019

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 14, 2020

Completed
7 months until next milestone

Study Start

First participant enrolled

August 24, 2020

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

June 4, 2020

Status Verified

June 1, 2020

Enrollment Period

2.9 years

First QC Date

December 27, 2019

Last Update Submit

June 2, 2020

Conditions

MalnutritionPolypharmacyAged

Keywords

MalnutritionPolypharmacyDrug side effectsNutritional improvementMedication review

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline Body weight at 24th week

    measurement of the participants weight

    Baseline, 24th week

Secondary Outcomes (8)

  • Change from Baseline Health- related quality of life at 24th week

    Baseline, 24th week

  • Change from Baseline Activity of Daily living (ADL) at 24th week

    Baseline, 24th week

  • Change from Baseline Admission to nursing home at 24th week

    Baseline, 24th week

  • Change from Baseline Admission to hospital at 24th week

    Baseline, 24th week

  • Change from Baseline Mini Nutritional Assessment short form (MNA-SF) at 24th week

    Baseline, 24th week

  • +3 more secondary outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL

Drug review and tailored nutritional supply.

Dietary Supplement: Individualized plan for improvement of nutritionDrug: Systematic drug review

Control group

NO INTERVENTION

Follow-up by home nurse service and family physician "as usual".

Interventions

Individualized plan for improvement of nutritionDIETARY_SUPPLEMENT

For each participant we will make a plan, describing different items the can improve their nutritional status: enrichment of food, dental care,

Intervention group
Systematic drug reviewDRUG

Consider altering medication list if the patient has symptoms that may be attributed to adverse drug effects, in particular side effects as nausea, dry mouth or loss of appetite, and if drug-drug interactions or drug-disease interactions are likely to occur. Recommended changes in patient's medication list will be presented for the family physician who will hold the final decision to implement the suggested adjustments.

Intervention group

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age 70 year or more
  • Receiving home nurse care each second week or more often
  • Mini Nutritional Assessment short form (MNA-SF): 0-11 point (malnourished or at risk for malnutrition)

You may not qualify if:

  • Life expectance less than 6 month
  • Serious cognitive impairment
  • In need of enteral-/ parenteral nutrition
  • Not able to stand up for weight measure
  • The home care service are not responsible for medication delivery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Oslo, 4050, Norway

Location

MeSH Terms

Conditions

MalnutritionDrug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesChemically-Induced Disorders

Study Officials

  • Straand Jørund, Professor

    Institute of Health and Society, University of Oslo, Norway

    STUDY CHAIR

Central Study Contacts

Mari Fiske, phd

CONTACT

0047 92667311mari.fiske@medisin.uio.no

Straand Jørund, Professor

CONTACT

0047 82852523jorund.straand@edisin.uio.no

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A pragmatic clinical controlled study. Intervention in one municipality. Participants in neighbor municipality will comprise control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

December 27, 2019

First Posted

January 14, 2020

Study Start

August 24, 2020

Primary Completion

July 1, 2023

Study Completion

July 1, 2023

Last Updated

June 4, 2020

Record last verified: 2020-06

Locations

NO(1)