Back to resultsAn Innovative Rehabilitating Meals-on-wheels Service for Frail Old People
Primary Purpose
Undernutrition, Rehabilitation
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
rehabilitating meals-on-wheels service
Sponsored by
About this trial
This is an interventional supportive care trial for Undernutrition focused on measuring meals-on-wheels, home-dwelling older people
Eligibility Criteria
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)
Sites / Locations
- Municipality of Albertslund
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
rehabilitating meals-on-wheels service
Usual care
Arm Description
the intervention group will for 8 weeks receive a rehabilitating meals-on-wheels service
the control group will receive usual care
Outcomes
Primary Outcome Measures
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).
readmissions
measuring prevalence of hospital admissions within 30 days
protein intake
assessment of dietary intake of protein by means of a 24 hour recall
Secondary Outcome Measures
physical function
30-seconds chair stand
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.
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 ".
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.
Compliance
assessment of percentage of use of provided meals-on-wheel service
adverse events
assessment of adverse events related to the intervention, e..g number of partiicpants with nausea,
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03889184
Brief Title
An Innovative Rehabilitating Meals-on-wheels Service for Frail Old People
Official Title
An Innovative Rehabilitating Meals-on-wheels Service for Frail Old People
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
March 18, 2019 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
March 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Copenhagen
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 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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Undernutrition, Rehabilitation
Keywords
meals-on-wheels, home-dwelling older people
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
76 (Actual)
8. Arms, Groups, and Interventions
Arm Title
rehabilitating meals-on-wheels service
Arm Type
Experimental
Arm Description
the intervention group will for 8 weeks receive a rehabilitating meals-on-wheels service
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
the control group will receive usual care
Intervention Type
Other
Intervention Name(s)
rehabilitating meals-on-wheels service
Intervention Description
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 Outcome Measure Information:
Title
EuroQoL (EQ-5D-5l)
Description
(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).
Time Frame
change after 8 weeks
Title
readmissions
Description
measuring prevalence of hospital admissions within 30 days
Time Frame
after 30 days
Title
protein intake
Description
assessment of dietary intake of protein by means of a 24 hour recall
Time Frame
change after 8 weeks
Secondary Outcome Measure Information:
Title
physical function
Description
30-seconds chair stand
Time Frame
change after 8 weeks
Title
Satisfaction with food-related quality of life questionnaire (SWFL)
Description
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.
Time Frame
change after 8 weeks
Title
Food related functional ability questionnaire (scale)
Description
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 ".
Time Frame
change after 8 weeks
Title
Meal quality questionnaire
Description
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.
Time Frame
change after 8 weeks
Title
Compliance
Description
assessment of percentage of use of provided meals-on-wheel service
Time Frame
after 8 weeks
Title
adverse events
Description
assessment of adverse events related to the intervention, e..g number of partiicpants with nausea,
Time Frame
during the 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Marie Beck, PhD
Organizational Affiliation
University College Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Municipality of Albertslund
City
Albertslund
ZIP/Postal Code
2620
Country
Denmark
12. IPD Sharing Statement
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An Innovative Rehabilitating Meals-on-wheels Service for Frail Old People
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