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

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.

Study Overview

• Status: Completed
• Conditions: Frail Older Adults
• Intervention / Treatment: Behavioral: A rehabilitation process involving collaborative goal setting with a case manager about managing own food and meals

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark
    • The Danish Dietetic Association

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Controlgroup
Experimental: Interventionsgroup	Behavioral: A rehabilitation process involving collaborative goal setting with a case manager about managing own food and meals; The intervention consists of two parts: Education of the health care staff with three day's education focusing of aspects of food, meals and nutrition to old people.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 6 months
Weight	Weight in kilograms	Up to 6 months
Height	Height in meter and centimetre	Up to 6 months
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.	Up to 6 months
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.	Up to 6 months
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.	Up to 6 months
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).	Up to 6 months

Collaborators and Investigators

• Sponsor: The Danish Dietetic Association
• Collaborators: Metropolitan University College; National Board of Health, Denmark; The Danish Meal Partnership; Ministry of Environment and Food of Denmark; The City of Odense; Danish Diet & Nutrition Association
• Investigators: Study Director: Mette Pedersen, The Danish Dietetic Association

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2017
• Primary Completion (Actual): September 1, 2018
• Study Completion (Actual): September 1, 2018

Study Registration Dates

• First Submitted: September 16, 2017
• First Submitted That Met QC Criteria: September 20, 2017
• First Posted (Actual): September 21, 2017

Study Record Updates

• Last Update Posted (Actual): February 7, 2019
• Last Update Submitted That Met QC Criteria: February 6, 2019
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: PROJECT_APM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No