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Frail Older AdultsNCT03289598

Effect of Involving Community-dwelling Older Adults in Activities in Relation to Meals

A study testing A rehabilitation process involving collaborative goal setting with a case manager about managing own food and meals in people with Frail Older Adults, run by The Danish Dietetic Association at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Community-dwelling older adults receiving support at home such as meals-on-wheels may lose the ability to preserve social, cognitive, and functional abilities, when becoming accustomed to and dependent of community aged care. Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Frail Older Adults
What is being tested?
A rehabilitation process involving collaborative goal setting with a case manager about managing own food and meals
Could I receive a placebo?
No, everyone receives an active treatment
How many people
130 participants
Where
1 siteDenmark
Study dates
15 Feb 2017to 1 Sep 2018
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

  • Community dwelling older people (64+ years)
  • Able to eat and drink
  • Receive meals-on-wheels from the municipality at the time of recruitment
  • Live in the city of Odense

Who cannot join

  • Moderate-severe dementia as judged by the home -care staff
  • Being deaf and/or not understand the language of Danish.
  • Not being able to sign the informed consent
  • Receiving (or likely to receive in the next 6 months) enteral tube feeding or parenteral nutrition;
  • Participating in other project in the municipality about nutritional support in the form of dietetic advice;
  • Or on an end-of-life care pathway

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • The Danish Dietetic Association

    Copenhagen

Other trials in Denmark

About this study

Official title: A Cluster Randomised Feasibility Trial Evaluating Involving Community-dwelling Older Adults in Activities in Relation to Meals in a Rehabilitation Program; Recruitment, Data Collection and Protocol

Community-dwelling older adults receiving support at home such as meals-on-wheels may lose the ability to preserve social, cognitive, and functional abilities, when becoming accustomed to and dependent of community aged care. When still able to cook older adults often hold some control over the foods that are prepared and which they eat, and which helps to foster identity. The purpose of this study is to evaluate community-dwelling older adults being involved in activities in relation to meals in a rehabilitation program.

Being tested
A rehabilitation process involving collaborative goal setting with a case manager about managing own food and meals

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • A rehabilitation process involving collaborative goal setting with a case manager about managing own food and mealsBehavioural

    The intervention consists of two parts:

    1. Education of the health care staff with three day's education focusing of aspects of food, meals and nutrition to old people.
    2. The individual participants in the intervention group will be participating in a rehabilitation process involving collaborative goal setting with a case manager. All the case managers have a background as registered dietician and will before start of the intervention be trained in managing a rehabilitation process with focus on meals and food. The training will consist of three days of education in, respectively, areas in relation to rehabilitation and the role as a care manager. Specific topics include; assessment of functional abilities in relation to meals and food; goal setting by means of GAS (Goal Attainment Scaling), ethical considerations and communication.
Study groups in NCT03289598
Study groupRoleWhat they receive
InterventionsgroupExperimentalNot described
Receives: Behavioral: A rehabilitation process involving collaborative goal setting with a case manager about managing own food and meals
ControlgroupNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Quality of life

    EuroQol (EQ-5D) is a questionnaire with five questions to be answered in three categories of movement, self-care, usual activities, pain/discomfort and anxiety/depression.

    Measured: Up to 6 months

Secondary outcomes (7)

  1. 30 seconds chair-stand

    30 seconds chair-stand will be used to measure muscle strength. Participants are asked to fold their arms across their chest and to stand up and sit down on a chair without pushing off with arms, as many times as possible for 30 seconds.

    Measured: Up to 6 months

  2. Weight

    Weight in kilograms

    Measured: Up to 6 months

  3. Height

    Height in meter and centimetre

    Measured: Up to 6 months

  4. Loneliness

    Loneliness will be measured by the UCLA Loneliness Scale. The scale consists of 20 items (11 positive and 9 negative), describing subjective feelings of loneliness.

    Measured: Up to 6 months

  5. Mental well-being

    Mental well-being will be measured by the short Warwich-Edinburgh Mental Well-being Scale (SWEMWBS) - Danish version 2014. SWEMWBS is a 7-item scale; each answered on a 1 to 5 Likert scale, with most items representing aspects of psychological and eudemonic well-being, and few covering hedonic well-being or affect.

    Measured: Up to 6 months

  6. Self-efficacy

    Self-efficacy will be measured by The General Self-Efficacy Scale (GSE).The GSE is a 10-item psychometric scale will be used to assess optimistic self-beliefs to cope with a variety of difficult demands in life.

    Measured: Up to 6 months

  7. Satisfaction with food-related life

    The satisfaction with food-related life will be measured by the Satisfaction with Food-related Life (SWFL) scale.The SWFL, consists of 5 items grouped into a single dimension (e.g. Food 1: Food and meals are positive elements; Food 2: I am generally pleased with my food; Food 3: My life in relation to food and meals is close to ideal; Food 4: With regards to food, the conditions of my life are excellent; Food 5: Food and meals give me satisfaction in daily life.). In each scale, the respondents must indicate their degree of agreement with these statements using a 6-level Likert scale (1 = disagree completely, 6 = agree completely).

    Measured: Up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2017
  2. Study start15 Feb 2017
  3. Primary completion1 Sep 2018
  4. Study completion1 Sep 2018

Resources

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
130 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03289598
Sponsor's protocol ID
PROJECT_APM
Status last verified
Aug 2018
First submitted
16 Sep 2017
Last updated
7 Feb 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Husted MM, Beck AM, Ulrikkeholm LK. A cluster randomised feasibility pilot trial evaluating involving community-dwelling older adults in activities in relation to meals in a rehabilitation program; recruitment, data collection and protocol. Pilot Feasibility Stud. 2018 Aug 6;4:134. doi: 10.1186/s40814-018-0323-3. eCollection 2018.

    PubMed 30123525

Questions about this trial

What is this clinical trial studying?

A study testing A rehabilitation process involving collaborative goal setting with a case manager about managing own food and meals in people with Frail Older Adults, run by The Danish Dietetic Association 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 4 inclusion and 6 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 7 Feb 2019. 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?

Quality of life (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03289598, which also lists 1 linked publication.

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 7 Feb 2019.

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