An Innovative Rehabilitating Meals-on-wheels Service for Frail Old People

Study Overview
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Brief Summary
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The aim of the project is to assess the beneficial effect of offering frail old people a targeted meals-on-wheels service in 8 weeks in a randomized controlled trial

Detailed Description
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The aim of the project is to assess the beneficial effect of offering frail old people a targeted meals-on-wheels service in 8 weeks in a randomized controlled trial. The target group is, respectively old people discharged from an hospital stay, old people referred for exercise rehabilitation in the municipality and old people already receiving meals-on-wheels

Official Title
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An Innovative Rehabilitating Meals-on-wheels Service for Frail Old People

Conditions
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Undernutrition, Rehabilitation

Intervention / Treatment
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* Other: rehabilitating meals-on-wheels service


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 65+ year, able to speak and understand Danish. has accepted to participate Is discharged from hospital, or is referred to exercise rehabilitation in the municipality or is receiving meals-on-wheels Exclusion Criteria: terminal disease, living in a nursing home, receives a specific diet (e.g. diabetes, dysphagia, vegetarian or vegan)

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: rehabilitating meals-on-wheels service<br>the intervention group will for 8 weeks receive a rehabilitating meals-on-wheels service | Other: rehabilitating meals-on-wheels service<br>* the meals-on-wheels service will be specifically targeted for old people discharged from hospital, receiving exercise rehabilitation in the municipality or already receiving meals-on-wheels<br>|
| No Intervention: Usual care<br>the control group will receive usual care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EuroQoL (EQ-5D-5l) | (EQ-5D-3L) is a standardized instrument for use as a measure of health outcome. The EQ-5D-5L descriptive system comprises the following 5 dimensions (5D): mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels (5L): from no problems (1 point), to extreme problems (5 points). | change after 8 weeks | 
| readmissions | measuring prevalence of hospital admissions within 30 days | after 30 days | 
| protein intake | assessment of dietary intake of protein by means of a 24 hour recall | change after 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| physical function | 30-seconds chair stand | change after 8 weeks | 
| Satisfaction with food-related quality of life questionnaire (SWFL) | SWFL consist of five items that can be measured independently, or grouped into a single dimension. The participants evaluate their degree of agreement, with five statements of answer possibilities (from disagree completely to agree completely), and a higher level means a better SWFL score. | change after 8 weeks | 
| Food related functional ability questionnaire (scale) | Food-related functional ability is assessed based on questions of ability (or inability) to handle shopping, table coverage, cooking, heating and eating, as well as being able to chew and swallow food without problems and to see, hear, smell and taste food. There are four response categories from 'yes, effortlessly' to 'no, not at all'. In addition, six questions regarding the extent to which the participant can master daily chores regarding today's main meals. There are five response categories from  can not at all to to very much . | change after 8 weeks | 
| Meal quality questionnaire | meal quality is assessed on the basis of the Nutrition and Health Education's culinary assessment schedule, which includes seven assessment criteria, as well as supplementary questions about the correspondence between the citizen's expectations and the appearance of the food. The assessment criteria include sensory factors regarding the appearance of the food, fragrance, taste, consistency, temperature, portion size and overall assessment. The criteria are assessed on a Likert scale (1-5), where 1 is defined as very poor and 5 is defined very well. | change after 8 weeks | 
| Compliance | assessment of percentage of use of provided meals-on-wheel service | after 8 weeks | 
| adverse events | assessment of adverse events related to the intervention, e..g number of partiicpants with nausea, | during the 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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meals-on-wheels, home-dwelling older people