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Completed

NCT Number: NCT03889184

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

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

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Key information

Conditions

Undernutrition Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Rehabilitation

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Municipality of Albertslund

Albertslund, 2620, Denmark

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

rehabilitating meals-on-wheels service

Other

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

Primary outcomes

  1. EuroQoL (EQ-5D-5l)

    Time frame: change after 8 weeks

    (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).

  2. readmissions

    Time frame: after 30 days

    measuring prevalence of hospital admissions within 30 days

  3. protein intake

    Time frame: change after 8 weeks

    assessment of dietary intake of protein by means of a 24 hour recall

Secondary outcomes

  1. physical function

    Time frame: change after 8 weeks

    30-seconds chair stand

  2. Satisfaction with food-related quality of life questionnaire (SWFL)

    Time frame: change after 8 weeks

    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.

  3. Food related functional ability questionnaire (scale)

    Time frame: change after 8 weeks

    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 ".

  4. Meal quality questionnaire

    Time frame: change after 8 weeks

    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.

  5. Compliance

    Time frame: after 8 weeks

    assessment of percentage of use of provided meals-on-wheel service

  6. adverse events

    Time frame: during the 8 weeks

    assessment of adverse events related to the intervention, e..g number of partiicpants with nausea,

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Mar 26, 2019
Registry last updated
Jun 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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