An interventional study of Individualized plan for improvement of nutrition and Systematic drug review in Malnutrition, Polypharmacy and Aged, sponsored by University of Oslo. Status unknown at 1 site in Norway. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2020-06-04.
Sponsored by University of Oslo · Not applicable, Interventional, and Treatment
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.
1,587 studies on the registry are indexed under Malnutrition; 237 are open to participants now.
This study's planned enrollment of 50 is below the median of 90 across 1,134 interventional studies indexed under Malnutrition.
Browse Malnutrition studies →University of Oslo is the lead sponsor of 176 studies on the registry; 23 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug review and tailored nutritional supply.
Dietary Supplement: Individualized plan for improvement of nutrition · Drug: Systematic drug review
Follow-up by home nurse service and family physician "as usual".
For each participant we will make a plan, describing different items the can improve their nutritional status: enrichment of food, dental care,
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 Body weight at 24th week
measurement of the participants weight
Time frame: Baseline, 24th week
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.
Time frame: 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.
Time frame: Baseline, 24th week
Change from Baseline Admission to nursing home at 24th week
Changes in Number of admissions to nursing home
Time frame: Baseline, 24th week
Change from Baseline Admission to hospital at 24th week
Change in Number of admissions to hospital
Time frame: 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
Time frame: Baseline, 24th week
Change from Baseline Number of drugs in daily use at 24th week
Change in number of drugs in daily use
Time frame: 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
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.
See list Protocol page 21-23, attachment 2
Time frame: Baseline, 24th week
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University of Oslo