Pressure UlcersPhase 2NCT01877681
Reference Nurse Program for Pressure Ulcers in Primary Care
A Phase 2 study testing Tele-assistance and Active comparator in people with Pressure Ulcers, run by Basque Health Service.
Trial summary
Introduction: Pressure ulcers (PU) are the most common chronic wounds in all levels of care in health centers. The chronic wound care by skilled personnel is key to healing and management of these injuries. Read more about this study
- Who is it for?
- Ages 16 to 90 years
- Conditions the study is for
- Pressure Ulcers
- What is being tested?
- Tele-assistance and Active comparator
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- Oct 2012to Sep 2014
- Phase
- Phase 2
- 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 16 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- New cases of PU in Stage II-III, treated by the same nurse over time at patient's home. (Stage II: Partial loss of skin thickness that affects the epidermis, dermis, or both. Ulcer surface that looks like abrasion, blister, or shallow crater; Stage III: Full thickness loss of skin involving damage or necrosis of subcutaneous tissue that may extend down to but not through the underlying fascia)
Who cannot join
- Patients with chronic wounds that are not PU
- PU in patients with plastic surgery
- Patients who move periodically
- Patients requiring hospitalization during follow-up
- Patients in which nurse is expected to be changed during follow-up
- Terminal patients
About this study
Official title: Chronic Wounds Reference Nurse and Telematic Interconsultation Program for Pressure Ulcers in Primary Care: Evaluation of Effectiveness and Cost Reduction
Introduction: Pressure ulcers (PU) are the most common chronic wounds in all levels of care in health centers. The chronic wound care by skilled personnel is key to healing and management of these injuries. An inter-clinical telematic program for PU in Primary Care (PC) can improve the effectiveness of interventions and cost savings.
Objective: To evaluate the effectiveness and costs reduction after the implementation in PC setting of a chronic wounds reference nurse and a teleconsultation program aimed to nurses for the management of PU in patients in home care setting.
Methodology: A prospective pilot clinical trial in which 46 primary care nurses in Osakidetza will be randomly assigned to two parallel groups: experimental group and control group. Each nurse will recruit at least 1 new patient in home care with PU in stage II-III. The intervention will consist of a telematic advice from the reference nurse regarding chronic wound management in relation to a specific PU. Patients will be monitored for 8 weeks with a minimum of 4 repeated measurements of the Resvech Index 2.0. To evaluate the effectiveness of the intervention, multilevel models or linear mixed models to take into account the auto-correlation at the individual level and nurse, will be used
- Conditions
- Pressure Ulcers
- Being tested
- Tele-assistance, Active comparator
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tele-assistanceProcedure or surgery
Assisted care (Tele-assistance) provided by an expert nurse through a informatic online application
Active comparatorProcedure or surgery
Usual care as specified in the PU practice guideline
| Study group | Role | What they receive |
|---|---|---|
| Assisted Care | Experimental | Assisted care (Tele=assistance) provided by an expert nurse through a informatic online application Receives: Procedure: Tele-assistance |
| Active comparator | Active comparator | Usual care as stated by the Clinical Practice Guidelines for Pressure Ulcers treatment Receives: Procedure: Active comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
healing progression
healing progression as measured by the RESVECH scale by a blinded expert
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2013 (estimated)
- Study startOct 2012
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure UlcersStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Basque Health Service
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Cristina Quesada, Basque Health Service
- Investigators
- Cristina Quesada, Nurse, Principal investigator, Osakidetza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01877681
- Sponsor's protocol ID
- 2011111099
- Status last verified
- Apr 2015
- First submitted
- 12 Jun 2013
- Last updated
- 16 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Wounds Reference Nurse and Telematic Interconsultation Program for Pressure Ulcers in Primary Care: Evaluation of Effectiveness and Cost Reduction
- ClinicalTrials.gov ID
- NCT01877681
- Acronym / sponsor ID
- 2011111099
- Conditions
- Pressure Ulcers
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Basque Health ServiceOther government
- Study start
- Oct 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 14 Jun 2013 (estimated)
- 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.
Introduction: Pressure ulcers (PU) are the most common chronic wounds in all levels of care in health centers. The chronic wound care by skilled personnel is key to healing and management of these injuries. An inter-clinical telematic program for PU in Primary Care (PC) can improve the effectiveness of interventions and cost savings.
Objective: To evaluate the effectiveness and costs reduction after the implementation in PC setting of a chronic wounds reference nurse and a teleconsultation program aimed to nurses for the management of PU in patients in home care setting.
Methodology: A prospective pilot clinical trial in which 46 primary care nurses in Osakidetza will be randomly assigned to two parallel groups: experimental group and control group. Each nurse will recruit at least 1 new patient in home care with PU in stage II-III. The intervention will consist of a telematic advice from the reference nurse regarding chronic wound management in relation to a specific PU. Patients will be monitored for 8 weeks with a minimum of 4 repeated measurements of the Resvech Index 2.0. To evaluate the effectiveness of the intervention, multilevel models or linear mixed models to take into account the auto-correlation at the individual level and nurse, will be used
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Assisted Care | Experimental | Procedure: Tele-assistanceAssisted care (Tele=assistance) provided by an expert nurse through a informatic online application |
| Active comparator | Active comparator | Procedure: Active comparatorUsual care as stated by the Clinical Practice Guidelines for Pressure Ulcers treatment |
Who may qualify
- Ages
- 16 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- New cases of PU in Stage II-III, treated by the same nurse over time at patient's home. (Stage II: Partial loss of skin thickness that affects the epidermis, dermis, or both. Ulcer surface that looks like abrasion, blister, or shallow crater; Stage III: Full thickness loss of skin involving damage or necrosis of subcutaneous tissue that may extend down to but not through the underlying fascia)
Key exclusion criteria (6 listed)
- Patients with chronic wounds that are not PU
- PU in patients with plastic surgery
- Patients who move periodically
- Patients requiring hospitalization during follow-up
- Patients in which nurse is expected to be changed during follow-up
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 |
|---|---|---|
| Tele-assistanceAssisted care (Tele-assistance) provided by an expert nurse through a informatic online application | Procedure or surgery | Assisted Care |
| Active comparatorUsual care as specified in the PU practice guideline | Procedure or surgery | Active comparator |
Primary outcome
healing progression
Time frame: 8 weeks
healing progression as measured by the RESVECH scale by a blinded expert
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 16 Apr 2015.
Related trials for Pressure Ulcers
RecruitingPhase 4
Clinical Trial Evaluating a Single Layer Amniotic Membrane and Standard of Care in the Management of Nonhealing Pressure Ulcers
Pressure Ulcer, Ulcer, Pressure
Not yet recruiting
Comparison of Negative Pressure Wound Therapy Versus Moist Wound Dressing in Diabetic Foot Ulcer Patients
Diabetic Foot Ulcer
Recruiting
Physical Therapy Wound Care Modalities in Patients With Spinal Cord Injury (SCI)
Spinal Cord Injuries, Pressure Injuries
Recruiting
Implementing a Decision Support Tool to Prevent Community-Acquired Pressure Injury in Spinal Cord Injury (SCI) in the Spinal Cord Injury Clinic
Spinal Cord Injury, Pressure Injury
Not yet recruitingObservational study
Explainable AI for Prospective Pressure Injury Staging
Pressure Injury
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.
Cristina Quesada, Nurse principal investigator
Osakidetza
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tele-assistance and Active comparator in people with Pressure Ulcers, run by Basque Health Service.
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 6 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 16 Apr 2015. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
healing progression (time frame: 8 weeks). 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 16 Apr 2015.