MalnutritionNCT04229238
Nutritional Status and Medication Treatment in Home-dwelling Older Adults
An observational study of Malnutrition and Aged, 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 first study in this Project. The second study is described separately; Identification: 2017/12883-2 Malnutrition is common in older adults. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Malnutrition, Aged, Polypharmacy
- How many people
- 400 participants
- Where
- 1 siteNorway
- Study dates
- 10 May 2017to 30 Sep 2020
- Phase
- Observational
- 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
Study population: Older adults (70 +) receiving regular health care from the home nurse service. Setting is two rural municipalities in southern Norway.
Who may be able to join
- 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)
Who cannot join
- Patient or next of kin denies inclusion
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
University of Oslo, Institute for Health and Society, Department of General Practice
Oslo, 4050
Jørund Straand, Professor, 0047 92852523, jorund.straand@medisin.uio.no
Professor
About this study
Official title: 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.
Read the 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.
- Conditions
- Malnutrition, Aged, Polypharmacy
- Keywords
- Nutritional status, Polypharmacy, Home-dwelling, Potentially inappropriate medication use
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: week 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start10 May 2017
- Primary completion30 Sep 2020 (estimated)
- Study completion30 Sep 2020 (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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 400 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
- Jørund Straand, professor, Study chair, Institute of Health and Society, University of Oslo, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04229238
- Sponsor's protocol ID
- 2017/12883-1
- Other IDs
- 2017
- Status last verified
- Jan 2020
- First submitted
- 27 Dec 2019
- Last updated
- 18 Jan 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 18 Jan 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 I: Nutritional Status and Medication Treatment in Home-dwelling Older Adults. A Cross-sectional Study
- ClinicalTrials.gov ID
- NCT04229238
- Acronym / sponsor ID
- 2017/12883-1
- Conditions
- Malnutrition, Aged, Polypharmacy
- Keywords
- Nutritional status, Polypharmacy, Home-dwelling, Potentially inappropriate medication use
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Collaborators
- The Norwegian Research Fund for General Practice
- Study start
- 10 May 2017 (actual)
- Primary completion
- 30 Sep 2020 (estimated)
- Study completion
- 30 Sep 2020 (estimated)
- First posted
- 18 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 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.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Home-dwelling older adults | – | –Older adults (70 +) receiving regular health care from the home nursing service. Setting is two rural municipalities in southern Norway. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Older adults (70 +) receiving regular health care from the home nurse service. Setting is two rural municipalities in southern Norway.
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (1 listed)
- Patient or next of kin denies inclusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 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.
Jørund Straand, 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?
An observational study of Malnutrition and Aged, 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 5 inclusion and 1 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 18 Jan 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?
Nutritional status (time frame: week 1). The study lists 3 primary outcomes in all. 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 18 Jan 2020.