Malnutrition in Older Adults: An Intervention Based on Medication Review and Individual Nutritional Plan

Malnutrition Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04228900
• Other study ID #: 2017/12883-2
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 24, 2020
• Est. completion date: July 2023

Study information

• Verified date: June 2020
• Source: University of Oslo
• Contact: Mari Fiske, phd
• Phone: 0047 92667311
• Email: mari.fiske[@]medisin.uio.no
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: July 2023
• Est. primary completion date: July 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Aged
• Malnutrition
• Polypharmacy

Intervention

Dietary Supplement:
• Individualized plan for improvement of nutrition
For each participant we will make a plan, describing different items the can improve their nutritional status: enrichment of food, dental care,

Drug:
• Systematic drug review
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.

Locations

Country	Name	City	State
Norway	Department of General Practice, Institute og Health and Society, University og Oslo	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
University of Oslo	The Norwegian Research Fund for General Practice

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline Body weight at 24th week	measurement of the participants weight	Baseline, 24th week
Secondary	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
Secondary	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
Secondary	Change from Baseline Admission to nursing home at 24th week	Changes in Number of admissions to nursing home	Baseline, 24th week
Secondary	Change from Baseline Admission to hospital at 24th week	Change in Number of admissions to hospital	Baseline, 24th week
Secondary	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
Secondary	Change from Baseline Number of drugs in daily use at 24th week	Change in number of drugs in daily use	Baseline, 24th week
Secondary	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
Secondary	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