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.
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.
Norway1 site
Department of General Practice, Institute og Health and Society, University og Oslo
Oslo, 4050
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.
- Conditions
- Malnutrition, Polypharmacy, Aged
- 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 group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Drug review and tailored nutritional supply. Receives: Dietary Supplement: Individualized plan for improvement of nutrition; Drug: Systematic drug review |
| Control group | No intervention | Follow-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.
Change from Baseline Body weight at 24th week
measurement of the participants weight
Measured: Baseline, 24th week
Secondary outcomes (8)
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
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
Change from Baseline Admission to nursing home at 24th week
Changes in Number of admissions to nursing home
Measured: Baseline, 24th week
Change from Baseline Admission to hospital at 24th week
Change in Number of admissions to hospital
Measured: Baseline, 24th week
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
Change from Baseline Number of drugs in daily use at 24th week
Change in number of drugs in daily use
Measured: Baseline, 24th week
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
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.
- First posted14 Jan 2020
- Study start24 Aug 2020 (estimated)
- Primary completionJul 2023 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Collaborators
- The Norwegian Research Fund for General Practice
- Responsible party
- Principal investigator, Mari Fiske, University of Oslo
- Investigators
- Straand Jørund, Professor, Study chair, Institute of Health and Society, University of Oslo, Norway
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
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04228900
- Acronym / sponsor ID
- 2017/12883-2
- Conditions
- Malnutrition, Polypharmacy, Aged
- Keywords
- Malnutrition, Polypharmacy, Drug side effects, Nutritional improvement, Medication review
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Collaborators
- The Norwegian Research Fund for General Practice
- Study start
- 24 Aug 2020 (estimated)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 14 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A pragmatic clinical controlled study. Intervention in one municipality. Participants in neighbor municipality will comprise control group.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Dietary Supplement: Individualized plan for improvement of nutrition, Drug: Systematic drug reviewDrug review and tailored nutritional supply. |
| Control group | No intervention | –Follow-up by home nurse service and family physician "as usual". |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individualized plan for improvement of nutritionFor each participant we will make a plan, describing different items the can improve their nutritional status: enrichment of food, dental care, | Dietary supplement | Intervention group |
| Systematic drug reviewConsider 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. | Drug | Intervention group |
Primary outcome
Change from Baseline Body weight at 24th week
Time frame: Baseline, 24th week
measurement of the participants weight
8 secondary outcomes
Change from Baseline Health- related quality of life at 24th week
Time frame: Baseline, 24th week
Change from Baseline Activity of Daily living (ADL) at 24th week
Time frame: Baseline, 24th week
Change from Baseline Admission to nursing home at 24th week
Time frame: Baseline, 24th week
Change from Baseline Admission to hospital at 24th week
Time frame: Baseline, 24th week
Change from Baseline Mini Nutritional Assessment short form (MNA-SF) at 24th week
Time frame: Baseline, 24th week
Change from Baseline Number of drugs in daily use at 24th week
Time frame: Baseline, 24th week
Change from Baseline Number of drugs in daily use considered inappropriate at 24th week
Time frame: Baseline, 24th week
Change from Baseline Number of drugs in daily with high risk causing nausea, loss of appetite, and dry mouth at 24th week.
Time frame: Baseline, 24th week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Straand Jørund, Professor study chair
Institute of Health and Society, University of Oslo, Norway
1 site in 1 country: see every site and its status.
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.