Pressure Injury PreventionNCT06832345
The Effect of Web-Based Training and Counseling Given to Caregivers on the Pressure Injury Risk, Level of Dependence-Independence, and Caregivers' Burden of Care in Bedridden Patients
A study testing Experimental group in people with Pressure Injury Prevention, run by Istanbul University - Cerrahpasa.
Trial summary
Education and counseling of patients and caregivers, either face-to-face or using various communication technologies, are reported to have significant effects. Nurses are in a key position in the education and counseling of patients and their relatives for the prevention of pressure injury. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Pressure Injury Prevention
- What is being tested?
- Experimental group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2025to 1 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient;
- Being over 18 years of age
- Being open to communication (Mini Mental Test Score \>25 points),
- Medium or high risk according to the Braden pressure injury assessment scale (score ≤14 according to the Braden pressure injury risk assessment scale)
- Being at least a moderately dependent patient according to the Barthel Index (score ≤90 according to the Barthel Index) The caregiver;
- Being primarily responsible for patient care,
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- Being over 18 years of age
- Having a family bond with the patient,
- No monthly fee for providing care, (except for those receiving a monthly care pension from the state)
- Lack of healthcare workers (physician, midwife, nurse),
- Ability to read and write,
- Having a smartphone and internet access,
- Accepting a home visit,
- There is no physical or psychiatric obstacle that prevents communication,
Who cannot join
- The patient;
- Having cancer,
- Having an active skin disease,
- Blood glucose and blood pressure are not under control,
- Use of medication that may be associated with pressure injury (corticosteroid, immunosuppressive, sedative medication, antineoplastic medication, norepinephrine) is an exclusion criterion from the study.
- Criteria for Exclusion from the Study The patient;
- The patient is hospitalized,
- The patient\'s exitus is a criterion for exclusion from the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Education and counseling of patients and caregivers, either face-to-face or using various communication technologies, are reported to have significant effects. Nurses are in a key position in the education and counseling of patients and their relatives for the prevention of pressure injury. Although the share of health technologies in the management of pressure injury is important, it is also important for nurses to use these technologies. Web-based education, which is a part of health technologies, is defined as an education and training program created by using the features of internet and computer technologies.
Read the detailed description
To prevent pressure injuries; It has been determined that there are a limited number of studies in which training, telephone monitoring and counseling are provided to caregivers The originality of this study, which was conducted to evaluate the effect of web-based training given to caregivers on the pressure injury development of bedridden patients, addiction independence level and care burden of caregivers; The training is designed as web-based and creates a guide that caregivers can use during the care process.
- Conditions
- Pressure Injury Prevention
- Being tested
- Experimental group
- Keywords
- pressure injury prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental groupOther
Web-based training will be shared with patient relatives before the patient is discharged. A home visit will be made 2-3 days after the patient is discharged. Data collection forms will be collected by the researcher at each home visit. A total of four home visits and eight telephone follow-ups will be made within two months.
| Study group | Role | What they receive |
|---|---|---|
| interventions to be applied to the experimental group (web-based training and consultancy ) | Other | Web-based education and counseling services will be provided as an intervention. Web-based education will be provided to the caregiver in the patient's room in two face-to-face sessions within forty-eight hours before the patient is discharged. Counseling will include telephone follow-up and home visits after discharge. Telephone follow-up will be done once a week, for a total of 8 times, and home visits will be done 3 times over an 8-week period. The results will be assessed using the Braden Pressure Injury Risk Scale, Barthell Index, and data collection tools for patients in the experimental group, and the Zarit Caregiver Burden Scale will be used for caregivers. Receives: Other: Experimental group |
| interventions to be applied to the control group | Other | Caregivers in the control group will receive routine nursing care and no intervention will be made. At the end of the study, the website and educational content will be shared with patients and their relatives. Receives: Other: Experimental group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Findings regarding sociodemographic characteristics
Evaluation of data that may be related to pressure injuries for patients and caregivers.
Data such as patient\'s age, height, weight, chronic diseases and data such as caregivers\' age, inclination, and caregiving duration will be evaluated as averages and percentages.
Measured: 8 weeks, "up to two months".
Evaluation of the results regarding the patient's level of dependency and independence
According to the total scores of the Barthell Life Activities Index; 0-20 points: "Fully dependent", 21-61 points: "Extremely dependent", 62-90 points: "Moderately dependent", 91-99 points: "Mildly dependent" and 100 points: "Fully independent"
Measured: 8 weeks, "up to two months".
Assessment of patient's pressure injury risk score
According to the braden pressure injury risk assessment scale: The total scale score is between 6 and 23. As the scores from the scale decrease, the risk of developing a pressure injury increases. Individuals with a scale score of 12 and below are considered to be at high risk for developing a pressure injury, those with a score of 13-14 are considered to be at medium risk, and those with a score of 15-16 are considered to be at low risk. According to the inclusion criteria for this study, patients must be assessed as high and medium risk according to the Braden pressure injury risk assessment scale.
Measured: 8 weeks, "up to two months".
Results regarding the caregiver's care burden
According to the zarit caregiver burden scale: If the resulting score is between 22-46 points, it is defined as 'light load', if it is between 47-55 points, it is defined as 'moderate load', and if it is between 56-110 points, it is defined as 'severe load'.
Measured: 8 weeks, "up to two months".
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start1 Mar 2025 (estimated)
- Primary completion1 May 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure Injury PreventionStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 31 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Şerife Kelle Dikbaş, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06832345
- Sponsor's protocol ID
- interventation
- Status last verified
- Feb 2025
- First submitted
- 28 Jun 2024
- Last updated
- 18 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Web-Based Training and Counseling Given to Caregivers on the Pressure Injury Risk, Level of Dependence-Independence, and Caregivers' Burden of Care in Bedridden Patients
- ClinicalTrials.gov ID
- NCT06832345
- Acronym / sponsor ID
- interventation
- Conditions
- Pressure Injury Prevention
- Keywords
- pressure injury prevention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 18 Feb 2025 (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.
Education and counseling of patients and caregivers, either face-to-face or using various communication technologies, are reported to have significant effects. Nurses are in a key position in the education and counseling of patients and their relatives for the prevention of pressure injury. Although the share of health technologies in the management of pressure injury is important, it is also important for nurses to use these technologies. Web-based education, which is a part of health technologies, is defined as an education and training program created by using the features of internet and computer technologies.
Detailed description
To prevent pressure injuries; It has been determined that there are a limited number of studies in which training, telephone monitoring and counseling are provided to caregivers The originality of this study, which was conducted to evaluate the effect of web-based training given to caregivers on the pressure injury development of bedridden patients, addiction independence level and care burden of caregivers; The training is designed as web-based and creates a guide that caregivers can use during the care process.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| interventions to be applied to the experimental group (web-based training and consultancy ) | Other | Other: Experimental groupWeb-based education and counseling services will be provided as an intervention. Web-based education will be provided to the caregiver in the patient's room in two face-to-face sessions within forty-eight hours before the patient is discharged. Counseling will include telephone follow-up and home visits after discharge. Telephone follow-up will be done once a week, for a total of 8 times, and home visits will be done 3 times over an 8-week period. The results will be assessed using the Braden Pressure Injury Risk Scale, Barthell Index, and data collection tools for patients in the experimental group, and the Zarit Caregiver Burden Scale will be used for caregivers. |
| interventions to be applied to the control group | Other | Other: Experimental groupCaregivers in the control group will receive routine nursing care and no intervention will be made. At the end of the study, the website and educational content will be shared with patients and their relatives. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- The patient;
- Being over 18 years of age
- Being open to communication (Mini Mental Test Score \>25 points),
- Medium or high risk according to the Braden pressure injury assessment scale (score ≤14 according to the Braden pressure injury risk assessment scale)
- Being at least a moderately dependent patient according to the Barthel Index (score ≤90 according to the Barthel Index) The caregiver;
Key exclusion criteria (8 listed)
- The patient;
- Having cancer,
- Having an active skin disease,
- Blood glucose and blood pressure are not under control,
- Use of medication that may be associated with pressure injury (corticosteroid, immunosuppressive, sedative medication, antineoplastic medication, norepinephrine) is an exclusion criterion from the study.
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 |
|---|---|---|
| Experimental groupWeb-based training will be shared with patient relatives before the patient is discharged. A home visit will be made 2-3 days after the patient is discharged. Data collection forms will be collected by the researcher at each home visit. A total of four home visits and eight telephone follow-ups will be made within two months. | Other | interventions to be applied to the control group, interventions to be applied to the experimental group (web-based training and consultancy ) |
Primary outcome
Findings regarding sociodemographic characteristics
Time frame: 8 weeks, "up to two months".
Evaluation of data that may be related to pressure injuries for patients and caregivers. Data such as patient\'s age, height, weight, chronic diseases and data such as caregivers\' age, inclination, and caregiving duration will be evaluated as averages and percentages.
Evaluation of the results regarding the patient's level of dependency and independence
Time frame: 8 weeks, "up to two months".
According to the total scores of the Barthell Life Activities Index; 0-20 points: "Fully dependent", 21-61 points: "Extremely dependent", 62-90 points: "Moderately dependent", 91-99 points: "Mildly dependent" and 100 points: "Fully independent"
Assessment of patient's pressure injury risk score
Time frame: 8 weeks, "up to two months".
According to the braden pressure injury risk assessment scale: The total scale score is between 6 and 23. As the scores from the scale decrease, the risk of developing a pressure injury increases. Individuals with a scale score of 12 and below are considered to be at high risk for developing a pressure injury, those with a score of 13-14 are considered to be at medium risk, and those with a score of 15-16 are considered to be at low risk. According to the inclusion criteria for this study, patients must be assessed as high and medium risk according to the Braden pressure injury risk assessment scale.
Results regarding the caregiver's care burden
Time frame: 8 weeks, "up to two months".
According to the zarit caregiver burden scale: If the resulting score is between 22-46 points, it is defined as 'light load', if it is between 47-55 points, it is defined as 'moderate load', and if it is between 56-110 points, it is defined as 'severe load'.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2025.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental group in people with Pressure Injury Prevention, run by Istanbul University - Cerrahpasa.
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 14 inclusion and 8 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: opening soon, as of the sponsor's last update on 18 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Serife KELLE DIKBAS, Lecturer (+9005382033050, serifekelle2@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Findings regarding sociodemographic characteristics (time frame: 8 weeks, "up to two months".). 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 18 Feb 2025.