Malnutrition in Older Adults: An Intervention Based on Medication Review and Individual Nutritional Plan
Primary Purpose
Malnutrition, Polypharmacy, Aged
Status
Unknown status
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Individualized plan for improvement of nutrition
Systematic drug review
Sponsored by
About this trial
This is an interventional treatment trial for Malnutrition focused on measuring Malnutrition, Polypharmacy, Drug side effects, Nutritional improvement, Medication review
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.
Sites / Locations
- Department of General Practice, Institute og Health and Society, University og Oslo
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention group
Control group
Arm Description
Drug review and tailored nutritional supply.
Follow-up by home nurse service and family physician "as usual".
Outcomes
Primary Outcome Measures
Change from Baseline Body weight at 24th week
measurement of the participants weight
Secondary Outcome Measures
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.
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.
Change from Baseline Admission to nursing home at 24th week
Changes in Number of admissions to nursing home
Change from Baseline Admission to hospital at 24th week
Change in Number of admissions to hospital
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
Change from Baseline Number of drugs in daily use at 24th week
Change in number of drugs in daily use
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
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
Full Information
NCT ID
NCT04228900
First Posted
December 27, 2019
Last Updated
June 2, 2020
Sponsor
University of Oslo
Collaborators
The Norwegian Research Fund for General Practice
1. Study Identification
Unique Protocol Identification Number
NCT04228900
Brief Title
Malnutrition in Older Adults: An Intervention Based on Medication Review and Individual Nutritional Plan
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 24, 2020 (Anticipated)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oslo
Collaborators
The Norwegian Research Fund for General Practice
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition, Polypharmacy, Aged
Keywords
Malnutrition, Polypharmacy, Drug side effects, Nutritional improvement, Medication review
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A pragmatic clinical controlled study. Intervention in one municipality. Participants in neighbor municipality will comprise control group.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Drug review and tailored nutritional supply.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Follow-up by home nurse service and family physician "as usual".
Intervention Type
Dietary Supplement
Intervention Name(s)
Individualized plan for improvement of nutrition
Intervention Description
For each participant we will make a plan, describing different items the can improve their nutritional status: enrichment of food, dental care,
Intervention Type
Drug
Intervention Name(s)
Systematic drug review
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Baseline Body weight at 24th week
Description
measurement of the participants weight
Time Frame
Baseline, 24th week
Secondary Outcome Measure Information:
Title
Change from Baseline Health- related quality of life at 24th week
Description
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
Title
Change from Baseline Activity of Daily living (ADL) at 24th week
Description
Assessed by Barthel´s ADL-index. Minimum score 0, Maximum score 20. The higher score the better.
Time Frame
Baseline, 24th week
Title
Change from Baseline Admission to nursing home at 24th week
Description
Changes in Number of admissions to nursing home
Time Frame
Baseline, 24th week
Title
Change from Baseline Admission to hospital at 24th week
Description
Change in Number of admissions to hospital
Time Frame
Baseline, 24th week
Title
Change from Baseline Mini Nutritional Assessment short form (MNA-SF) at 24th week
Description
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
Title
Change from Baseline Number of drugs in daily use at 24th week
Description
Change in number of drugs in daily use
Time Frame
Baseline, 24th week
Title
Change from Baseline Number of drugs in daily use considered inappropriate at 24th week
Description
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
Title
Change from Baseline Number of drugs in daily with high risk causing nausea, loss of appetite, and dry mouth at 24th week.
Description
See list Protocol page 21-23, attachment 2
Time Frame
Baseline, 24th week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mari Fiske, phd
Phone
0047 92667311
Email
mari.fiske@medisin.uio.no
First Name & Middle Initial & Last Name or Official Title & Degree
Straand Jørund, Professor
Phone
0047 82852523
Email
jorund.straand@edisin.uio.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Straand Jørund, Professor
Organizational Affiliation
Institute of Health and Society, University of Oslo, Norway
Official's Role
Study Chair
Facility Information:
Facility Name
Department of General Practice, Institute og Health and Society, University og Oslo
City
Oslo
ZIP/Postal Code
4050
Country
Norway
12. IPD Sharing Statement
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Malnutrition in Older Adults: An Intervention Based on Medication Review and Individual Nutritional Plan
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