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

NCT ID: NCT04228900

Last Updated: 2020-06-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-24
• Study Completion Date: 2023-07-31

Brief 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.

Detailed 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.

Conditions

Malnutrition; Polypharmacy; Aged

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention group

Drug review and tailored nutritional supply.

Group Type: EXPERIMENTAL

Individualized plan for improvement of nutrition

Intervention Type: DIETARY_SUPPLEMENT

For each participant we will make a plan, describing different items the can improve their nutritional status: enrichment of food, dental care,

Systematic drug review

Intervention Type: 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.

Control group

Follow-up by home nurse service and family physician "as usual".

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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,

Intervention Type: DIETARY_SUPPLEMENT

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Norwegian Research Fund for General Practice

UNKNOWN

Sponsor Role: collaborator

University of Oslo

OTHER

Sponsor Role: lead

Responsible Party

Mari Fiske

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Straand Jørund, Professor

Role: STUDY_CHAIR

Institute of Health and Society, University of Oslo, Norway

Locations

Department of General Practice, Institute og Health and Society, University og Oslo

Oslo, , Norway

Countries

Norway

Central Contacts

Mari Fiske, phd

Role: CONTACT

mari.fiske@medisin.uio.no

0047 92667311

Straand Jørund, Professor

Role: CONTACT

jorund.straand@edisin.uio.no

0047 82852523

Provided Documents

Document Type: Informed Consent Form: participant, intervention group

View Document

Document Type: Informed Consent Form: next of kin, intervention group

View Document

Document Type: Informed Consent Form: participant, control group

View Document

Document Type: Informed Consent Form: next of kin, control group

View Document

Document Type: Study Protocol

View Document

Other Identifiers

2017/12883-2

Identifier Type: -

Identifier Source: org_study_id