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

Rehabilitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03889184
• Other study ID #: DGK
• Status: Completed
• Phase: N/A
• Start date: March 18, 2019
• Est. completion date: March 1, 2020

Study information

• Verified date: June 2020
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: March 1, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Malnutrition
• Rehabilitation
• Undernutrition

Intervention

Other:
• rehabilitating meals-on-wheels service
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

Locations

Country	Name	City	State
Denmark	Municipality of Albertslund	Albertslund

Sponsors (1)

Lead Sponsor	Collaborator
University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	readmissions	measuring prevalence of hospital admissions within 30 days	after 30 days
Primary	protein intake	assessment of dietary intake of protein by means of a 24 hour recall	change after 8 weeks
Secondary	physical function	30-seconds chair stand	change after 8 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	Compliance	assessment of percentage of use of provided meals-on-wheel service	after 8 weeks
Secondary	adverse events	assessment of adverse events related to the intervention, e..g number of partiicpants with nausea,	during the 8 weeks