<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/NCT02214758</url>
  </required_header>
  <id_info>
    <org_study_id>RECID84/2012</org_study_id>
    <nct_id>NCT02214758</nct_id>
  </id_info>
  <brief_title>Optimising Nutrition, Oral Health and Medication for Older Home Care Clients (NutOrMed)</brief_title>
  <acronym>NutOrMed</acronym>
  <official_title>Optimising Nutrition, Oral Health and Medication for Older Home Care Clients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Eastern Finland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Eastern Finland</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study is to evaluate the impact of six month long nutritional and oral health&#xD;
      intervention on nutritional status, oral health, functional performance and hospital&#xD;
      admission/costs on older persons using home care services. Additionally, participants are&#xD;
      interviewed at home regarding their drugs use and this information will be compared with&#xD;
      medication information in electronic patient records.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">May 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in nutritional status on the Mini Nutritional Assessment (MNA) test and s-albumin level at months 6</measure>
    <time_frame>Baseline, Month 6</time_frame>
    <description>Using MNA test and s-albumin level test</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in oral health status on clinical oral health examination and in-home interview at months 6</measure>
    <time_frame>Baseline, Month 6</time_frame>
    <description>Clinical oral health examination included type and location of removable dental prosthesis, examination of the oral mucosa, number and location of teeth, condition of teeth, presence of plaque, gingival bleeding and measurement of periodontal pockets. In-home interview included questions about dental and denture hygiene, a subjective feeling of dry mouth and pain in mouth</description>
  </secondary_outcome>
  <other_outcome>
    <measure>The agreement between medication in-home interview and EMR in baseline</measure>
    <time_frame>baseline</time_frame>
    <description>A pharmacist recorded each prescription and non-prescription medication and complementary and alternative medicine supplements used regularly, as-needed within a week or in the past on the basis of the interview, medication lists, packages and prescriptions at the baseline. All medications were encoded using the ATC (Anatomic Therapeutic Chemical) classification (WHO). The medication list from the locally used electronic medical record (EMR) was gathered from the same day than in-home interview</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">300</enrollment>
  <condition>Nutrition, Oral Health</condition>
  <arm_group>
    <arm_group_label>Dietary counseling</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Oral health counseling</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>nutrition no counseling</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>oral health no counseling</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Nutrition and oral health interventions</intervention_name>
    <description>On the basis of a blood test, Mini Nutritional Assessment, and nutritional anamnesis, the nutritionist developed a plan for individualised nutritional care and discussed with the participant and her/his nurse or family members. If the participants seemed unable to increase the energy and/or protein of their diet, daily complementary dietary drinks were recommended to them. After the dental hygienist interview and oral health examination, the participants in need were targeted for oral health intervention. The intervention included individualised instructions on either dental hygiene, denture hygiene, cleaning of the oral mucosa or for dry mouth. The participants were re-examined six months after the baseline interviews to evaluate the effectiveness of the interventions. Both the intervention and control groups had the same examinations as with the exception of the nutritional and oral health intervention.</description>
    <arm_group_label>Dietary counseling</arm_group_label>
    <arm_group_label>Oral health counseling</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  home care clients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  under 75 years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>75 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Irma Nykänen, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Eastern Finland</affiliation>
  </overall_official>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 4, 2014</study_first_submitted>
  <study_first_submitted_qc>August 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 12, 2014</study_first_posted>
  <last_update_submitted>August 8, 2014</last_update_submitted>
  <last_update_submitted_qc>August 8, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 12, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Eastern Finland</investigator_affiliation>
    <investigator_full_name>Irma Nykänen</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <keyword>Home care clients, nutrition, oral health, medication</keyword>
  <!-- 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/NCT02214758
org study id: RECID84/2012
nct id: NCT02214758
lead sponsor: 
has dmc: Yes
The aim of the study is to evaluate the impact of six month long nutritional and oral health
      intervention on nutritional status, oral health, functional performance and hospital
      admission/costs on older persons using home care services. Additionally, participants are
      interviewed at home regarding their drugs use and this information will be compared with
      medication information in electronic patient records.
allocation: Non-Randomized
intervention model: Factorial Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Change from baseline in nutritional status on the Mini Nutritional Assessment (MNA) test and s-albumin level at months 6
time frame: Baseline, Month 6
description: Using MNA test and s-albumin level test
measure: Change from baseline in oral health status on clinical oral health examination and in-home interview at months 6
time frame: Baseline, Month 6
description: Clinical oral health examination included type and location of removable dental prosthesis, examination of the oral mucosa, number and location of teeth, condition of teeth, presence of plaque, gingival bleeding and measurement of periodontal pockets. In-home interview included questions about dental and denture hygiene, a subjective feeling of dry mouth and pain in mouth
measure: The agreement between medication in-home interview and EMR in baseline
time frame: baseline
description: A pharmacist recorded each prescription and non-prescription medication and complementary and alternative medicine supplements used regularly, as-needed within a week or in the past on the basis of the interview, medication lists, packages and prescriptions at the baseline. All medications were encoded using the ATC (Anatomic Therapeutic Chemical) classification (WHO). The medication list from the locally used electronic medical record (EMR) was gathered from the same day than in-home interview
arm group label: Dietary counseling
arm group type: Other
arm group label: Oral health counseling
arm group type: Other
arm group label: nutrition no counseling
arm group type: No Intervention
arm group label: oral health no counseling
arm group type: No Intervention
intervention type: Other
intervention name: Nutrition and oral health interventions
description: On the basis of a blood test, Mini Nutritional Assessment, and nutritional anamnesis, the nutritionist developed a plan for individualised nutritional care and discussed with the participant and her/his nurse or family members. If the participants seemed unable to increase the energy and/or protein of their diet, daily complementary dietary drinks were recommended to them. After the dental hygienist interview and oral health examination, the participants in need were targeted for oral health intervention. The intervention included individualised instructions on either dental hygiene, denture hygiene, cleaning of the oral mucosa or for dry mouth. The participants were re-examined six months after the baseline interviews to evaluate the effectiveness of the interventions. Both the intervention and control groups had the same examinations as with the exception of the nutritional and oral health intervention.
arm group label: Dietary counseling
arm group label: Oral health counseling
criteria: 
gender: All
minimum age: 75 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Irma Nykänen, PhD
role: Principal Investigator
affiliation: University of Eastern Finland
responsible party type: Principal Investigator
investigator affiliation: University of Eastern Finland
investigator full name: Irma Nykänen
investigator title: PhD