FootNCT03837002
Effect of The Foot Care Protocol Applied to Elderly People
A study testing foot care protocol in people with Foot, run by Ordu University at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Foot
- What is being tested?
- foot care protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Apr 2017to 5 Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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),
Who cannot join
- Elderly people who are diagnosed with Diabetes Mellitus
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ahmet Cemal Mağden Nursing Home
Ordu, Altınordu, 52100
About this study
Official title: Effect of The Foot Care Protocol Applied to Elderly People on Foot Health Problems and Foot Care Behaviors
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.
Read the detailed 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.
- Conditions
- Foot
- Being tested
- foot care protocol
- Keywords
- Foot Disease, Foot Care Protocol, Nursing Care
- Medical subject headings
- Foot Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
foot care protocolOther
foot assesment, foot care, foot care education
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: foot care protocol |
| Control | No intervention | foot examination at the first interview, foot examination at the last interview (six month) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 6th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2019
- Study start28 Apr 2017
- Primary completion16 Jun 2017
- Study completion5 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FootStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized-controlled trail
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ordu University
- Sponsor type
- University, hospital or other
- Collaborators
- TC Erciyes University
- Responsible party
- Principal investigator, Aslıhan ÇATIKER, Ordu University
- Investigators
- Aslıhan Çatıker, Phd, Principal investigator, Ordu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03837002
- Sponsor's protocol ID
- Study 1
- Status last verified
- Feb 2019
- First submitted
- 6 Feb 2019
- Last updated
- 11 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of The Foot Care Protocol Applied to Elderly People on Foot Health Problems and Foot Care Behaviors
- ClinicalTrials.gov ID
- NCT03837002
- Acronym / sponsor ID
- Study 1
- Conditions
- Foot
- Keywords
- Foot Disease, Foot Care Protocol, Nursing Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Ordu UniversityUniversity, hospital or other
- Collaborators
- TC Erciyes University
- Study start
- 28 Apr 2017 (actual)
- Primary completion
- 16 Jun 2017 (actual)
- Study completion
- 5 Feb 2018 (actual)
- First posted
- 11 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- randomized-controlled trail
| Arm | Type | Receives |
|---|---|---|
| foot care protocol | Experimental | Other: foot care protocolfoot 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) |
| Control | No intervention | –foot examination at the first interview, foot examination at the last interview (six month) |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- 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),
Key exclusion criteria (1 listed)
- Elderly people who are diagnosed with Diabetes Mellitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| foot care protocolfoot assesment, foot care, foot care education | Other | foot care protocol |
Primary outcome
Change from foot examination questionnaire at baseline and sixth month
Time frame: Baseline, 6th 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.
Change from foot care knowledge form at baseline and sixth month
Time frame: Baseline, 6th 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.
Change from foot self care observation guide at baseline and sixth month
Time frame: Baseline, 6th 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.
Change from falling questionnaire at baseline and sixth month
Time frame: Baseline, 6th month
This questionnaire was developed by the researchers and evaluated the number of elderly people.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aslıhan Çatıker, Phd principal investigator
Ordu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing foot care protocol in people with Foot, run by Ordu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from foot examination questionnaire at baseline and sixth month (time frame: Baseline, 6th month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2019.