<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03289598</url>
  </required_header>
  <id_info>
    <org_study_id>PROJECT_APM</org_study_id>
    <nct_id>NCT03289598</nct_id>
  </id_info>
  <brief_title>Effect of Involving Community-dwelling Older Adults in Activities in Relation to Meals</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Danish Dietetic Association</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Danish Meal Partnership</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ministry of Environment and Food of Denmark</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Metropolitan University College</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Board of Health, Denmark</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The City of Odense</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Danish Diet &amp; Nutrition Association</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The Danish Dietetic Association</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Community-dwelling older adults receiving support at home such as meals-on-wheels may lose&#xD;
      the ability to preserve social, cognitive, and functional abilities, when becoming accustomed&#xD;
      to and dependent of community aged care. When still able to cook older adults often hold some&#xD;
      control over the foods that are prepared and which they eat, and which helps to foster&#xD;
      identity. The purpose of this study is to evaluate community-dwelling older adults being&#xD;
      involved in activities in relation to meals in a rehabilitation program.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 15, 2017</start_date>
  <completion_date type="Actual">September 1, 2018</completion_date>
  <primary_completion_date type="Actual">September 1, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Single Blind</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Quality of life</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>30 seconds chair-stand</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Weight in kilograms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Height</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Height in meter and centimetre</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Loneliness</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mental well-being</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-efficacy</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with food-related life</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">130</enrollment>
  <condition>Frail Older Adults</condition>
  <arm_group>
    <arm_group_label>Interventionsgroup</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Controlgroup</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>A rehabilitation process involving collaborative goal setting with a case manager about managing own food and meals</intervention_name>
    <description>The intervention consists of two parts:&#xD;
Education of the health care staff with three day's education focusing of aspects of food, meals and nutrition to old people.&#xD;
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.</description>
    <arm_group_label>Interventionsgroup</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Community dwelling older people (64+ years)&#xD;
&#xD;
          -  Able to eat and drink&#xD;
&#xD;
          -  Receive meals-on-wheels from the municipality at the time of recruitment&#xD;
&#xD;
          -  Live in the city of Odense&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Moderate-severe dementia as judged by the home -care staff&#xD;
&#xD;
          -  Being deaf and/or not understand the language of Danish.&#xD;
&#xD;
          -  Not being able to sign the informed consent&#xD;
&#xD;
          -  Receiving (or likely to receive in the next 6 months) enteral tube feeding or&#xD;
             parenteral nutrition;&#xD;
&#xD;
          -  Participating in other project in the municipality about nutritional support in the&#xD;
             form of dietetic advice;&#xD;
&#xD;
          -  Or on an end-of-life care pathway&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mette Pedersen</last_name>
    <role>Study Director</role>
    <affiliation>The Danish Dietetic Association</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Danish Dietetic Association</name>
      <address>
        <city>Copenhagen</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>September 16, 2017</study_first_submitted>
  <study_first_submitted_qc>September 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 21, 2017</study_first_posted>
  <last_update_submitted>February 6, 2019</last_update_submitted>
  <last_update_submitted_qc>February 6, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 7, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03289598
org study id: PROJECT_APM
nct id: NCT03289598
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Outcomes Assessor)
masking description: Single Blind
measure: Quality of life
time frame: Up to 6 months
description: 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.
measure: 30 seconds chair-stand
time frame: Up to 6 months
description: 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.
measure: Weight
time frame: Up to 6 months
description: Weight in kilograms
measure: Height
time frame: Up to 6 months
description: Height in meter and centimetre
measure: Loneliness
time frame: Up to 6 months
description: 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.
measure: Mental well-being
time frame: Up to 6 months
description: 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.
measure: Self-efficacy
time frame: Up to 6 months
description: 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.
measure: Satisfaction with food-related life
time frame: Up to 6 months
description: 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).
arm group label: Interventionsgroup
arm group type: Experimental
arm group label: Controlgroup
arm group type: No Intervention
intervention type: Behavioral
intervention name: A rehabilitation process involving collaborative goal setting with a case manager about managing own food and meals
description: 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.
arm group label: Interventionsgroup
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Mette Pedersen
role: Study Director
affiliation: The Danish Dietetic Association
facility: 
country: Denmark
responsible party type: Sponsor
sharing ipd: Undecided