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

Frail Older Adults Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03289598
• Other study ID #: PROJECT_APM
• Status: Completed
• Phase: N/A
• Start date: February 15, 2017
• Est. completion date: September 1, 2018

Study information

• Verified date: August 2018
• Source: The Danish Dietetic Association
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: September 1, 2018
• Est. primary completion date: September 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Frail Older Adults

Intervention

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.

Locations

Country	Name	City	State
Denmark	The Danish Dietetic Association	Copenhagen

Sponsors (7)

Lead Sponsor	Collaborator
The Danish Dietetic Association	Danish Diet & Nutrition Association, Metropolitan University College, Ministry of Environment and Food of Denmark, National Board of Health, Denmark, The City of Odense, The Danish Meal Partnership

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Weight	Weight in kilograms	Up to 6 months
Secondary	Height	Height in meter and centimetre	Up to 6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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