Effect of Involving Community-dwelling Older Adults in Activities in Relation to Meals
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
1 other identifier
interventional
130
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 15, 2017
CompletedFirst Submitted
Initial submission to the registry
September 16, 2017
CompletedFirst Posted
Study publicly available on registry
September 21, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2018
CompletedFebruary 7, 2019
August 1, 2018
1.5 years
September 16, 2017
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
EXPERIMENTALControlgroup
NO INTERVENTIONInterventions
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.
Eligibility Criteria
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
- The Danish Dietetic Associationlead
- The Danish Meal Partnershipcollaborator
- Ministry of Environment and Food of Denmarkcollaborator
- Metropolitan University Collegecollaborator
- National Board of Health, Denmarkcollaborator
- The City of Odensecollaborator
- Danish Diet & Nutrition Associationcollaborator
Study Sites (1)
The Danish Dietetic Association
Copenhagen, Denmark
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.
PMID: 30123525DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Mette Pedersen
The Danish Dietetic Association
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