NCT03837002

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 28, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 16, 2017

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2018

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

February 6, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 11, 2019

Completed
Last Updated

February 11, 2019

Status Verified

February 1, 2019

Enrollment Period

2 months

First QC Date

February 6, 2019

Last Update Submit

February 8, 2019

Conditions

Keywords

Foot DiseaseFoot Care ProtocolNursing Care

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

foot care protocol

EXPERIMENTAL

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)

Other: foot care protocol

Control

NO INTERVENTION

foot examination at the first interview, foot examination at the last interview (six month)

Interventions

foot assesment, foot care, foot care education

foot care protocol

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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),

You may not qualify if:

  • Elderly people who are diagnosed with Diabetes Mellitus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahmet Cemal Mağden Nursing Home

Ordu, Altınordu, 52100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Foot Diseases

Condition Hierarchy (Ancestors)

Musculoskeletal DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Aslıhan Çatıker, Phd

    Ordu University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: randomized-controlled trail
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 6, 2019

First Posted

February 11, 2019

Study Start

April 28, 2017

Primary Completion

June 16, 2017

Study Completion

February 5, 2018

Last Updated

February 11, 2019

Record last verified: 2019-02

Locations