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

Sponsor
University of Copenhagen (Other)
Overall Status
Completed
CT.gov ID
NCT03889184
Collaborator
(none)
76
1
2
11.5
6.6

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Other: rehabilitating meals-on-wheels service
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
76 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized studyRandomized study
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
An Innovative Rehabilitating Meals-on-wheels Service for Frail Old People
Actual Study Start Date :
Mar 18, 2019
Actual Primary Completion Date :
Dec 31, 2019
Actual Study Completion Date :
Mar 1, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. EuroQoL (EQ-5D-5l) [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 [after 30 days]

    measuring prevalence of hospital admissions within 30 days

  3. protein intake [change after 8 weeks]

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

Secondary Outcome Measures

  1. physical function [change after 8 weeks]

    30-seconds chair stand

  2. Satisfaction with food-related quality of life questionnaire (SWFL) [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) [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 [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 [after 8 weeks]

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

  6. adverse events [during the 8 weeks]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Municipality of Albertslund Albertslund Denmark 2620

Sponsors and Collaborators

  • University of Copenhagen

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Anne Marie Beck, senior associate professor, University of Copenhagen
ClinicalTrials.gov Identifier:
NCT03889184
Other Study ID Numbers:
  • DGK
First Posted:
Mar 26, 2019
Last Update Posted:
Jun 9, 2020
Last Verified:
Jun 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Anne Marie Beck, senior associate professor, University of Copenhagen
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 9, 2020