<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/NCT03837002</url>
  </required_header>
  <id_info>
    <org_study_id>Study 1</org_study_id>
    <nct_id>NCT03837002</nct_id>
  </id_info>
  <brief_title>Effect of The Foot Care Protocol Applied to Elderly People</brief_title>
  <official_title>Effect of The Foot Care Protocol Applied to Elderly People on Foot Health Problems and Foot Care Behaviors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>T.C. ORDU ÜNİVERSİTESİ</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>TC Erciyes University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>T.C. ORDU ÜNİVERSİTESİ</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>
      The study was carried out randomized-controlled experimental research to determine the foot&#xD;
      health status and factors affecting it among elderly individuals, to develop a protective and&#xD;
      developmental protocol for foot health of elderly individuals and to determine the effect of&#xD;
      this protocol on foot health problems, foot care knowledge levels and foot care behaviors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Data for the foot health status and factors affecting it among elderly individuals were&#xD;
      collected from 28 April 2017 to 5 February 2018. The population of the study comprised 132&#xD;
      elderly individuals living in Nursing Home linked to the Ministry of Family and Social&#xD;
      Policies in Ordu Central County. In the research, 118 individuals in the nursing home were&#xD;
      reached, the research began with 65 elderly individuals abiding by the inclusion criteria&#xD;
      randomized into experimental and control groups and was completed with 57 individuals&#xD;
      (experiment: 28, control: 29). Data were collected using the standardized mini mental test,&#xD;
      elderly descriptive form, foot examination form, foot care knowledge level form, foot care&#xD;
      behavior scale, falling form.. Ethics committee permission, organization permission and&#xD;
      written informed consent from individuals were obtained. Five interviews were performed with&#xD;
      elderly individuals in the experimental group, while only two interviews were held with&#xD;
      elderly individuals in the control group to apply the data collection tools.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 28, 2017</start_date>
  <completion_date type="Actual">February 5, 2018</completion_date>
  <primary_completion_date type="Actual">June 16, 2017</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>
    <intervention_model_description>randomized-controlled trail</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from foot examination questionnaire at baseline and sixth month</measure>
    <time_frame>Baseline, 6th month</time_frame>
    <description>This questionnaire was developed by the researchers and evaluated the foot health of elderly people. It contains 26 questions in three part section. This form enables the determination of the diseases / problems in the foot.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from foot care knowledge form at baseline and sixth month</measure>
    <time_frame>Baseline, 6th month</time_frame>
    <description>This form was developed by researchers and evaluated the level of knowledge of foot care. It contains 10 questions. This form evaluated on total score (minimum:0, maximum:10). Higher values represent a better outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from foot self care observation guide at baseline and sixth month</measure>
    <time_frame>Baseline, 6th month</time_frame>
    <description>This scale evaluates the level of foot care behaviors of people. It contains 15 item. This scale evaluated on total score (minimum:15, maximum:75). Higher values represent a better outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from falling questionnaire at baseline and sixth month</measure>
    <time_frame>Baseline, 6th month</time_frame>
    <description>This questionnaire was developed by the researchers and evaluated the number of elderly people.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">57</enrollment>
  <condition>Foot</condition>
  <arm_group>
    <arm_group_label>foot care protocol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>foot examination at the first interview, foot care and training once a month and weekly follow-up for 3 months, foot examination at the last interview (six month)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>foot examination at the first interview, foot examination at the last interview (six month)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>foot care protocol</intervention_name>
    <description>foot assesment, foot care, foot care education</description>
    <arm_group_label>foot care protocol</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Living in nursing home during the research process, Not dependent on bed, Self-sufficient,&#xD;
        No communication problem, Elderly people have good cognitive functions ,(According to the&#xD;
        revised mini mental test) Elderly people with any foot problem (dermatological,&#xD;
        orthopaedic, circulation, sensory problems, problems related to the feet, self-care&#xD;
        problems),&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Elderly people who are diagnosed with Diabetes Mellitus&#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>Aslıhan Çatıker, Phd</last_name>
    <role>Principal Investigator</role>
    <affiliation>T.C. ORDU ÜNİVERSİTESİ</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ahmet Cemal Mağden Nursing Home</name>
      <address>
        <city>Ordu</city>
        <state>Altınordu</state>
        <zip>52100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 6, 2019</study_first_submitted>
  <study_first_submitted_qc>February 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 11, 2019</study_first_posted>
  <last_update_submitted>February 8, 2019</last_update_submitted>
  <last_update_submitted_qc>February 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 11, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>T.C. ORDU ÜNİVERSİTESİ</investigator_affiliation>
    <investigator_full_name>Aslıhan ÇATIKER</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Foot Disease</keyword>
  <keyword>Foot Care Protocol</keyword>
  <keyword>Nursing Care</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/NCT03837002
org study id: Study 1
nct id: NCT03837002
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study was carried out randomized-controlled experimental research to determine the foot
      health status and factors affecting it among elderly individuals, to develop a protective and
      developmental protocol for foot health of elderly individuals and to determine the effect of
      this protocol on foot health problems, foot care knowledge levels and foot care behaviors.
Data for the foot health status and factors affecting it among elderly individuals were
      collected from 28 April 2017 to 5 February 2018. The population of the study comprised 132
      elderly individuals living in Nursing Home linked to the Ministry of Family and Social
      Policies in Ordu Central County. In the research, 118 individuals in the nursing home were
      reached, the research began with 65 elderly individuals abiding by the inclusion criteria
      randomized into experimental and control groups and was completed with 57 individuals
      (experiment: 28, control: 29). Data were collected using the standardized mini mental test,
      elderly descriptive form, foot examination form, foot care knowledge level form, foot care
      behavior scale, falling form.. Ethics committee permission, organization permission and
      written informed consent from individuals were obtained. Five interviews were performed with
      elderly individuals in the experimental group, while only two interviews were held with
      elderly individuals in the control group to apply the data collection tools.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: randomized-controlled trail
primary purpose: Prevention
masking: Single (Participant)
measure: Change from foot examination questionnaire at baseline and sixth month
time frame: Baseline, 6th month
description: This questionnaire was developed by the researchers and evaluated the foot health of elderly people. It contains 26 questions in three part section. This form enables the determination of the diseases / problems in the foot.
measure: Change from foot care knowledge form at baseline and sixth month
time frame: Baseline, 6th month
description: This form was developed by researchers and evaluated the level of knowledge of foot care. It contains 10 questions. This form evaluated on total score (minimum:0, maximum:10). Higher values represent a better outcome.
measure: Change from foot self care observation guide at baseline and sixth month
time frame: Baseline, 6th month
description: This scale evaluates the level of foot care behaviors of people. It contains 15 item. This scale evaluated on total score (minimum:15, maximum:75). Higher values represent a better outcome.
measure: Change from falling questionnaire at baseline and sixth month
time frame: Baseline, 6th month
description: This questionnaire was developed by the researchers and evaluated the number of elderly people.
arm group label: foot care protocol
arm group type: Experimental
description: foot examination at the first interview, foot care and training once a month and weekly follow-up for 3 months, foot examination at the last interview (six month)
arm group label: Control
arm group type: No Intervention
description: foot examination at the first interview, foot examination at the last interview (six month)
intervention type: Other
intervention name: foot care protocol
description: foot assesment, foot care, foot care education
arm group label: foot care protocol
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Aslıhan Çatıker, Phd
role: Principal Investigator
affiliation: T.C. ORDU ÜNİVERSİTESİ
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: T.C. ORDU ÜNİVERSİTESİ
investigator full name: Aslıhan ÇATIKER
investigator title: Principal Investigator