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

Study Overview

• Status: Completed
• Conditions: Rehabilitation; Undernutrition
• Intervention / Treatment: Other: rehabilitating meals-on-wheels service

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

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Albertslund, Denmark, 2620
    • Municipality of Albertslund

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: rehabilitating meals-on-wheels service; the intervention group will for 8 weeks receive a rehabilitating meals-on-wheels service	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
No Intervention: Usual care; the control group will receive usual care

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Copenhagen
• Investigators: Principal Investigator: Anne Marie Beck, PhD, University College Copenhagen

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2019
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): March 1, 2020

Study Registration Dates

• First Submitted: March 19, 2019
• First Submitted That Met QC Criteria: March 21, 2019
• First Posted (Actual): March 26, 2019

Study Record Updates

• Last Update Posted (Actual): June 9, 2020
• Last Update Submitted That Met QC Criteria: June 7, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: meals-on-wheels; home-dwelling older people
• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition
• Other Study ID Numbers: DGK

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No