NCT03889184

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 18, 2019

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 19, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 26, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

June 9, 2020

Status Verified

June 1, 2020

Enrollment Period

10 months

First QC Date

March 19, 2019

Last Update Submit

June 7, 2020

Conditions

Keywords

meals-on-wheelshome-dwelling older people

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (6)

  • physical function

    change after 8 weeks

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

    change after 8 weeks

  • Food related functional ability questionnaire (scale)

    change after 8 weeks

  • Meal quality questionnaire

    change after 8 weeks

  • Compliance

    after 8 weeks

  • +1 more secondary outcomes

Study Arms (2)

rehabilitating meals-on-wheels service

EXPERIMENTAL

the intervention group will for 8 weeks receive a rehabilitating meals-on-wheels service

Other: rehabilitating meals-on-wheels service

Usual care

NO INTERVENTION

the control group will receive usual care

Interventions

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

rehabilitating meals-on-wheels service

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • + 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

You may not qualify if:

  • terminal disease,
  • living in a nursing home,
  • receives a specific diet (e.g. diabetes, dysphagia, vegetarian or vegan)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Municipality of Albertslund

Albertslund, 2620, Denmark

Location

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Anne Marie Beck, PhD

    University College Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomized study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
senior associate professor

Study Record Dates

First Submitted

March 19, 2019

First Posted

March 26, 2019

Study Start

March 18, 2019

Primary Completion

December 31, 2019

Study Completion

March 1, 2020

Last Updated

June 9, 2020

Record last verified: 2020-06

Locations