UndernutritionNCT03889184
An Innovative Rehabilitating Meals-on-wheels Service for Frail Old People
A study testing rehabilitating meals-on-wheels service in people with Undernutrition and Rehabilitation, run by University of Copenhagen at 1 site in Denmark.
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 Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Undernutrition, Rehabilitation
- What is being tested?
- rehabilitating meals-on-wheels service
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteDenmark
- Study dates
- 18 Mar 2019to 1 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- terminal disease,
- living in a nursing home,
- receives a specific diet (e.g. diabetes, dysphagia, vegetarian or vegan)
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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
- Conditions
- Undernutrition, Rehabilitation
- Being tested
- rehabilitating meals-on-wheels service
- Keywords
- meals-on-wheels, home-dwelling older people
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rehabilitating meals-on-wheels serviceOther
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
| Study group | Role | What they receive |
|---|---|---|
| rehabilitating meals-on-wheels service | Experimental | the intervention group will for 8 weeks receive a rehabilitating meals-on-wheels service Receives: Other: rehabilitating meals-on-wheels service |
| Usual care | No intervention | the control group will receive usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: change after 8 weeks
readmissions
measuring prevalence of hospital admissions within 30 days
Measured: after 30 days
protein intake
assessment of dietary intake of protein by means of a 24 hour recall
Measured: change after 8 weeks
Secondary outcomes (6)
physical function
30-seconds chair stand
Measured: 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.
Measured: 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 ".
Measured: 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.
Measured: change after 8 weeks
Compliance
assessment of percentage of use of provided meals-on-wheel service
Measured: after 8 weeks
adverse events
assessment of adverse events related to the intervention, e..g number of partiicpants with nausea,
Measured: during the 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study start18 Mar 2019
- Primary completion31 Dec 2019
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UndernutritionStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized study
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne Marie Beck, University of Copenhagen
- Investigators
- Anne Marie Beck, PhD, Principal investigator, University College Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03889184
- Sponsor's protocol ID
- DGK
- Status last verified
- Jun 2020
- First submitted
- 19 Mar 2019
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Innovative Rehabilitating Meals-on-wheels Service for Frail Old People
- ClinicalTrials.gov ID
- NCT03889184
- Acronym / sponsor ID
- DGK
- Conditions
- Undernutrition, Rehabilitation
- Keywords
- meals-on-wheels, home-dwelling older people
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- 18 Mar 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 26 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized study
| Arm | Type | Receives |
|---|---|---|
| rehabilitating meals-on-wheels service | Experimental | Other: rehabilitating meals-on-wheels servicethe intervention group will for 8 weeks receive a rehabilitating meals-on-wheels service |
| Usual care | No intervention | –the control group will receive usual care |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- terminal disease,
- living in a nursing home,
- receives a specific diet (e.g. diabetes, dysphagia, vegetarian or vegan)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rehabilitating meals-on-wheels servicethe 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 | Other | rehabilitating meals-on-wheels service |
Primary outcome
EuroQoL (EQ-5D-5l)
Time frame: 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).
readmissions
Time frame: after 30 days
measuring prevalence of hospital admissions within 30 days
protein intake
Time frame: change after 8 weeks
assessment of dietary intake of protein by means of a 24 hour recall
6 secondary outcomes
physical function
Time frame: change after 8 weeks
Satisfaction with food-related quality of life questionnaire (SWFL)
Time frame: change after 8 weeks
Food related functional ability questionnaire (scale)
Time frame: change after 8 weeks
Meal quality questionnaire
Time frame: change after 8 weeks
Compliance
Time frame: after 8 weeks
adverse events
Time frame: during the 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Marie Beck, PhD principal investigator
University College Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rehabilitating meals-on-wheels service in people with Undernutrition and Rehabilitation, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EuroQoL (EQ-5D-5l) (time frame: change after 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2020.