Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Aged
  • Malnutrition
  • Polypharmacy
Type
Interventional
Phase
Not Applicable
Design
Allocation: Non-RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: A pragmatic clinical controlled study. Intervention in one municipality. Participants in neighbor municipality will comprise control group.Masking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 70 years and 125 years
Gender
Both males and females

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, c...

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.

Tracking Information

NCT #
NCT04228900
Collaborators
The Norwegian Research Fund for General Practice
Investigators
Study Chair: Straand Jørund, Professor Institute of Health and Society, University of Oslo, Norway