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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03837002
Other study ID # Study 1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 28, 2017
Est. completion date February 5, 2018

Study information

Verified date February 2019
Source T.C. ORDU ÜNIVERSITESI
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 57
Est. completion date February 5, 2018
Est. primary completion date June 16, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria:

Living in nursing home during the research process, Not dependent on bed, Self-sufficient, No communication problem, Elderly people have good cognitive functions ,(According to the revised mini mental test) Elderly people with any foot problem (dermatological, orthopaedic, circulation, sensory problems, problems related to the feet, self-care problems),

Exclusion Criteria:

Elderly people who are diagnosed with Diabetes Mellitus

Study Design


Related Conditions & MeSH terms


Intervention

Other:
foot care protocol
foot assesment, foot care, foot care education

Locations

Country Name City State
Turkey Ahmet Cemal Magden Nursing Home Ordu Altinordu

Sponsors (2)

Lead Sponsor Collaborator
T.C. ORDU ÜNIVERSITESI Erciyes University Research Fund

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from foot examination questionnaire at baseline and sixth month 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. Baseline, 6th month
Primary Change from foot care knowledge form at baseline and sixth month 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. Baseline, 6th month
Primary Change from foot self care observation guide at baseline and sixth month 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. Baseline, 6th month
Primary Change from falling questionnaire at baseline and sixth month This questionnaire was developed by the researchers and evaluated the number of elderly people. Baseline, 6th month
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