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| Name | Class |
|---|---|
| The Norwegian Research Fund for General Practice | UNKNOWN |
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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:
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:
Component B: Nutritional intervention- individual nutrition plan. Drawing on the principles for good nutritional practice, and National guidelines, this component include the following considerations:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Drug review and tailored nutritional supply. |
|
| Control group | No Intervention | Follow-up by home nurse service and family physician "as usual". |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Individualized plan for improvement of nutrition | Dietary Supplement | For each participant we will make a plan, describing different items the can improve their nutritional status: enrichment of food, dental care, |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline Body weight at 24th week | measurement of the participants weight | Baseline, 24th week |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 24th week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mari Fiske, phd | Contact | 0047 92667311 | mari.fiske@medisin.uio.no | |
| Straand JĆørund, Professor | Contact | 0047 82852523 | jorund.straand@edisin.uio.no |
| Name | Affiliation | Role |
|---|---|---|
| Straand JĆørund, Professor | Institute of Health and Society, University of Oslo, Norway | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of General Practice, Institute og Health and Society, University og Oslo | Oslo | 4050 | Norway |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form: participant, intervention group | Jan 7, 2019 | Dec 27, 2019 | ICF_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: next of kin, intervention group | Jan 7, 2019 | Dec 27, 2019 | ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: participant, control group | Jan 7, 2019 | Dec 27, 2019 | ICF_002.pdf |
| ICF | No | No | Yes | Informed Consent Form: next of kin, control group | Jan 7, 2019 | Dec 27, 2019 | ICF_003.pdf |
| Prot | Yes | No | No | Study Protocol | Dec 17, 2019 | Jan 7, 2020 | Prot_004.pdf |
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| ID | Term |
|---|---|
| D044342 | Malnutrition |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D064419 | Chemically-Induced Disorders |
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A pragmatic clinical controlled study. Intervention in one municipality. Participants in neighbor municipality will comprise control group.
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| Systematic drug review | Drug | 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. |
|
| 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. |
| Baseline, 24th week |
| Change from Baseline Admission to nursing home at 24th week | Changes in Number of admissions to nursing home | Baseline, 24th week |
| Change from Baseline Admission to hospital at 24th week | Change in Number of admissions to hospital | 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 | Baseline, 24th week |
| Change from Baseline Number of drugs in daily use at 24th week | Change in number of drugs in daily use | 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 | 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 | Baseline, 24th week |