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MalnutritionNCT04228900

Malnutrition in Older Adults: An Intervention Based on Medication Review and Individual Nutritional Plan

A study testing Individualized plan for improvement of nutrition and Systematic drug review in people with Malnutrition and Polypharmacy, run by University of Oslo at 1 site in Norway.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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 second study in this Project. Read more about this study

Who is it for?
Ages 70 years and older
Conditions the study is for
Malnutrition, Polypharmacy, Aged
What is being tested?
Individualized plan for improvement of nutrition and Systematic drug review
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteNorway
Study dates
24 Aug 2020to Jul 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Straand Jørund, Professor contact

0047 82852523

jorund.straand@edisin.uio.no

Norway1 site
  • Department of General Practice, Institute og Health and Society, University og Oslo

    Oslo, 4050

Other trials in Norway

About this study

Official title: Nutrition and Medication Management in Home-dwelling Older Adults. Study II: Malnutrition in Older Adults: An Intervention Based on Medication Review and Individual Nutritional Plan

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.

Read more

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.
Read the detailed description

The participants will be recruited by the home nursing services or by a nurse at a short-time ward in the nursing home.

The composite intervention consists has two components (A and B):

Component A: Clinical assessment and critical medication review

Drawing on information from the medical history, clinical finding according to examination made by the principal investigator (trained physician), information from the General Practitioner (GP) and the findings from blood tests, we will make a systematic and critical medication review. This systematic review has the following considerations:

  • Are drug-drug unintended interactions likely to occur? Interaction analysis supported by https:// www.interaksjoner.no
  • Are there use of potentially inappropriate medication? Assessed based on the Norwegian General Practice Nursing -Home criteria.
  • Could nutritional related problems like loss of appetite, dry mouth and nausea, be attribute to adverse drug effects? Assessed by the list we made of drugs who often contributes to these side effects according to The Norwegian Pharmaceutical Product Compendium.

Component B: Nutritional intervention- individual nutrition plan. Drawing on the principles for good nutritional practice, and National guidelines, this component include the following considerations:

  • Nutritional status by use of Mini Nutritional Assessment short form (MNA-SF), and further in- depth nutrition assessment if MNA-SF is in range 0-11.
  • Assessment of the nutritional needs.
  • Assess food and drink intake with a 3- day dietary record to the estimated nutritional needs.
  • In collaboration with the home nurse, the participant and if possible/ necessary a next to kin, focusing on individual problems and develop an individual nutritional plan.

The project is about a controlled implementation of measures recommended in current national guidelines. We will follow a principle known as the "Nutritional Stairs", and choose interventions in the nutritional plan as close to "normal" food as possible. This means that the individual nutritional plan takes into account:

  • Physical and mental disorders are diagnosed and optimal treated. (Oral health care included)
  • Intervention to optimize the meal environment and meal itself, e.g., enough light in the room, specific tools to make eating possible if necessary, company
  • The frequency of meals, length of night fasting, special diets as energy- and nutrient dens diets, consistency customized diet (liquid or solid food)
  • Enriched food and in between meals/snacks
  • Nutritional supplements

The intervention last six months, and participants in the intervention group will receive four visits at home; baseline and after 4, 12 and 24 weeks. At baseline and at week 24, the principal investigator (trained physician) and the nurse will visit the participants. At week 4 and 12, only the nurse will visit them. The control group, are visited by a nurse twice: at baseline and after 24 weeks, and are follow-up by the home nurse service and their GP "as usual".

Drop- out during the study period and reasons for "loss to follow-up (LTFU)" will be registered; e.g., moved from the municipality, acute illness that make further participation difficult, admission to long time ward in nursing home, or any other reason to withdraw participation. In the intervention group, we will on behalf of and subject to the participant's consent, make an appointment for consultation by the GP, if the clinical assessment suggests undetected diseases or diseases not optimal treated. If oral health problems are encountered, we will recommend a consultation by a dentist.

Being tested
Individualized plan for improvement of nutrition, Systematic drug review
Keywords
Malnutrition, Polypharmacy, Drug side effects, Nutritional improvement, Medication review
Medical subject headings
Malnutrition, Drug-Related Side Effects and Adverse Reactions

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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,

  • 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.

Study groups in NCT04228900
Study groupRoleWhat they receive
Intervention groupExperimentalDrug review and tailored nutritional supply.
Receives: Dietary Supplement: Individualized plan for improvement of nutrition; Drug: Systematic drug review
Control groupNo interventionFollow-up by home nurse service and family physician "as usual".

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline Body weight at 24th week

    measurement of the participants weight

    Measured: Baseline, 24th week

Secondary outcomes (8)
  1. Change from Baseline Health- related quality of life at 24th week

    answered by one question:"Consider your health, would you say it is: excellent(score 5)- very good (score 4)- good (score 3)- pretty good (score 2)- bad(score 1)" minimum score 1, Maximum score 5.The higher score the better.

    Measured: Baseline, 24th week

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

    Assessed by Barthel´s ADL-index. Minimum score 0, Maximum score 20. The higher score the better.

    Measured: Baseline, 24th week

  3. Change from Baseline Admission to nursing home at 24th week

    Changes in Number of admissions to nursing home

    Measured: Baseline, 24th week

  4. Change from Baseline Admission to hospital at 24th week

    Change in Number of admissions to hospital

    Measured: Baseline, 24th week

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

    minimum score 0, Maximum score 14. 0-7 indicate malnutrition, 8-11 indicate risk for malnutrition, 12-14; normal nutritional status

    Measured: Baseline, 24th week

  6. Change from Baseline Number of drugs in daily use at 24th week

    Change in number of drugs in daily use

    Measured: Baseline, 24th week

  7. Change from Baseline Number of drugs in daily use considered inappropriate at 24th week

    Number of drugs considered inappropriate according to the Norwegian Practice Nursing-Home criteria, se protocol page 19-20,attachment 1

    Measured: Baseline, 24th week

  8. Change from Baseline Number of drugs in daily with high risk causing nausea, loss of appetite, and dry mouth at 24th week.

    See list Protocol page 21-23, attachment 2

    Measured: Baseline, 24th week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jan 2020
  2. Study start24 Aug 2020 (estimated)
  3. Primary completionJul 2023 (estimated)
  4. Study completionJul 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
A pragmatic clinical controlled study. Intervention in one municipality. Participants in neighbor municipality will comprise control group.
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04228900
Sponsor's protocol ID
2017/12883-2
Other IDs
2017
Status last verified
Jun 2020
First submitted
27 Dec 2019
Last updated
4 Jun 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Individualized plan for improvement of nutrition and Systematic drug review in people with Malnutrition and Polypharmacy, run by University of Oslo at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Mari Fiske, phd (0047 92667311, mari.fiske@medisin.uio.no), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline Body weight at 24th week (time frame: Baseline, 24th week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2020.

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