NCT03289598

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2017

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

February 15, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 21, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

February 7, 2019

Status Verified

August 1, 2018

Enrollment Period

1.5 years

First QC Date

September 16, 2017

Last Update Submit

February 6, 2019

Conditions

Outcome Measures

Primary Outcomes (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.

    Up to 6 months

Secondary Outcomes (7)

  • 30 seconds chair-stand

    Up to 6 months

  • Weight

    Up to 6 months

  • Height

    Up to 6 months

  • Loneliness

    Up to 6 months

  • Mental well-being

    Up to 6 months

  • +2 more secondary outcomes

Study Arms (2)

Interventionsgroup

EXPERIMENTAL
Behavioral: A rehabilitation process involving collaborative goal setting with a case manager about managing own food and meals

Controlgroup

NO INTERVENTION

Interventions

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.

Interventionsgroup

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Danish Dietetic Association

Copenhagen, Denmark

Location

Related Publications (1)

  • 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.

MeSH Terms

Interventions

Meals

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Mette Pedersen

    The Danish Dietetic Association

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Single Blind
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2017

First Posted

September 21, 2017

Study Start

February 15, 2017

Primary Completion

September 1, 2018

Study Completion

September 1, 2018

Last Updated

February 7, 2019

Record last verified: 2018-08

Locations