Risk ReductionTEACHNCT01204619
Trial on Education And Clinical Outcomes for Home PD Patients (TEACH)
A study testing Intensive training group in people with Risk Reduction, run by Kook-Hwan Oh at 6 sites in South Korea.
Trial summary
Since the emergence of home peritoneal dialysis as an alternative to in-center hemodialysis for chronic renal replacement therapy in the late 1970s, the percentage of dialysis patients on PD has continued to decrease each year. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Risk Reduction
- What is being tested?
- Intensive training group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 6 sitesSouth Korea
- Study dates
- Dec 2010to Mar 2016
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Incident patients who have PD catheter insertion for starting PD with Baxter solutions
- > 20 yr of age
Who cannot join
- Patients who have undergone dialysis or received kidney transplant (note, however, that patients who are currently undergoing emergency hemodialysis temporarily right before the PD do not fall under the exclusion criteria.)
- Patients who are likely to receive kidney transplant or shift to hemodialysis within the following 1 year
- Patients diagnosed with acute inflammatory disease for the past three months
- Patients currently diagnosed with chronic inflammatory disease
- Currently pregnant or breastfeeding
- Patients who are involved in other clinical trial within 30 days prior to enrollment
Show all 9Show fewer
- Patients who are currently hospitalized in care facilities such as nursing home, etc., or those who are expected to be hospitalized for the duration of the clinical test
- Patients who cannot perform PD by themselves
- Patients considered by the person in charge of the clinical test to have difficulty in participating in this clinical test
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
South Korea6 sites
Hallym University Sacred Hospital Puyngchon
Anyang
Wonkwang University, Sanbon Medical Center
Gunpo, Gyeonggi-do
Gachon University Gil Hospital
Incheon
Eulji Medical Center
Seoul
Hallym University Sacred Hospital Gangdong
Seoul
Seoul National University Hospital
Seoul
About this study
Since the emergence of home peritoneal dialysis as an alternative to in-center hemodialysis for chronic renal replacement therapy in the late 1970s, the percentage of dialysis patients on PD has continued to decrease each year. There have been a growing concern and research on patient and technique survival of peritoneal dialysis versus hemodialysis to find influential factors for better clinical outcomes. Meanwhile, technique failure rates were significantly higher in small centers treating less than twenty five PD patients. And there was a result for better technique survival after the second year, among the patients trained at the BREC(Baxter Renal Education Center). Better technique survival in large centers can be assumed with not only their more experience with patient management but also their educational infrastructure compared to small-sized centers.
Throughout our experiences in the last 30 years, we have recognized that a major element of PD program is patient training, however few data are available in terms of the relationship between PD training and treatment outcome and mostly are retrospective and non-randomized. Moreover, the technique survival and patient survival were analyzed with no significant difference.
From the insight, we decided to study prospectively to evaluate the efficacy of well-structured education program in terms of various patient outcomes in incident patients on PD.
Read the detailed description
This study will be conducted as multi-center, open-label, randomized, controlled trial. One hundred four patient starting PD will be randomized into two training groups. Patients in the conventional training group (CG) will be given non-standardized in-center conventional training programs plus two sessions of training by home visit, while those in intensive training group (IG) given in-center conventional training programs plus repeated home visits regularly over 24-month period (total thirteen visits). The primary end point of the study is exit site infection (ESI). Secondary endpoints are peritonitis and all-cause infection. Generalized Estimating Equations will be used to assess the adjusted effect of training level on the ESI and Cox regression model employed to evaluate the effect on the peritonitis and other secondary outcomes.
- Conditions
- Risk Reduction
- Being tested
- Intensive training group
- Keywords
- peritoneal dialysis
- Medical subject headings
- Risk Reduction Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive training groupBehavioural
an extra structured patient centric training program on PD technique and diet according to the developed training curriculum
| Study group | Role | What they receive |
|---|---|---|
| Conventional training group | No intervention | in-center conventional training programs + two home visits |
| Intensive training group | Experimental | in-center conventional training programs + an extra structured patient home visits repeatedly and regularly Receives: Behavioral: Intensive training group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exit site infection
Measured: 24 months
Secondary outcomes (23)
time to the first peritonitis
Measured: 24 months
Number of ESIs per patient-month
Measured: 24 months
Days of hospitalization per year
Measured: 24 months
Systolic pressure and diastolic pressure measured at every visit
Measured: 24 months
Average number of antihypertensive medications
Measured: 24 months
Kt/V
Measured: 24 months
Residual renal function
Measured: 24 months
Fluid balance score
Measured: 24 months
Patient survival rate
Measured: 24 months
Total medical cost
Measured: 24 months
Total hours of education and training
Measured: 24 months
Unplanned home visit and education by peritoneal dialysis nurse
Measured: 24 months
Compliance score of patients
Measured: 24 months
HbA1c only for patients with diabetes
Measured: 24 months
Intact PTH level
Measured: 24 months
Hemoglobin level
Measured: 24 months
nPNA
Measured: 24 months
QOL
Measured: 24 months
SGA
Measured: 24 months
K level
Measured: 24 months
Total number of hospitalizations by cause over the last 1 and/or 2 years after the dialysis
Measured: 24 months
Technical survival rate
Measured: 24 months
peritonitis rate
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2010 (estimated)
- Study startDec 2010
- Primary completionJul 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Risk ReductionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kook-Hwan Oh
- Sponsor type
- University, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Responsible party
- Sponsor-investigator, Kook-Hwan Oh, Seoul National University Hospital
- Investigators
- Kook-Hwan Oh, M.D., PhD, Principal investigator, Seoul National University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01204619
- Sponsor's protocol ID
- TEACH
- Acronym
- TEACH
- Status last verified
- Apr 2016
- First submitted
- 16 Sep 2010
- Last updated
- 14 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial on Education And Clinical Outcomes for Home PD Patients (TEACH)
- ClinicalTrials.gov ID
- NCT01204619
- Acronym / sponsor ID
- TEACH / TEACH
- Conditions
- Risk Reduction
- Keywords
- peritoneal dialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Kook-Hwan OhUniversity, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Study start
- Dec 2010
- Primary completion
- Jul 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 17 Sep 2010 (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.
Since the emergence of home peritoneal dialysis as an alternative to in-center hemodialysis for chronic renal replacement therapy in the late 1970s, the percentage of dialysis patients on PD has continued to decrease each year. There have been a growing concern and research on patient and technique survival of peritoneal dialysis versus hemodialysis to find influential factors for better clinical outcomes. Meanwhile, technique failure rates were significantly higher in small centers treating less than twenty five PD patients. And there was a result for better technique survival after the second year, among the patients trained at the BREC(Baxter Renal Education Center). Better technique survival in large centers can be assumed with not only their more experience with patient management but also their educational infrastructure compared to small-sized centers.
Throughout our experiences in the last 30 years, we have recognized that a major element of PD program is patient training, however few data are available in terms of the relationship between PD training and treatment outcome and mostly are retrospective and non-randomized. Moreover, the technique survival and patient survival were analyzed with no significant difference.
From the insight, we decided to study prospectively to evaluate the efficacy of well-structured education program in terms of various patient outcomes in incident patients on PD.
Detailed description
This study will be conducted as multi-center, open-label, randomized, controlled trial. One hundred four patient starting PD will be randomized into two training groups. Patients in the conventional training group (CG) will be given non-standardized in-center conventional training programs plus two sessions of training by home visit, while those in intensive training group (IG) given in-center conventional training programs plus repeated home visits regularly over 24-month period (total thirteen visits). The primary end point of the study is exit site infection (ESI). Secondary endpoints are peritonitis and all-cause infection. Generalized Estimating Equations will be used to assess the adjusted effect of training level on the ESI and Cox regression model employed to evaluate the effect on the peritonitis and other secondary outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional training group | No intervention | –in-center conventional training programs + two home visits |
| Intensive training group | Experimental | Behavioral: Intensive training groupin-center conventional training programs + an extra structured patient home visits repeatedly and regularly |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Incident patients who have PD catheter insertion for starting PD with Baxter solutions
- > 20 yr of age
Key exclusion criteria (9 listed)
- Patients who have undergone dialysis or received kidney transplant (note, however, that patients who are currently undergoing emergency hemodialysis temporarily right before the PD do not fall under the exclusion criteria.)
- Patients who are likely to receive kidney transplant or shift to hemodialysis within the following 1 year
- Patients diagnosed with acute inflammatory disease for the past three months
- Patients currently diagnosed with chronic inflammatory disease
- Currently pregnant or breastfeeding
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 |
|---|---|---|
| Intensive training groupan extra structured patient centric training program on PD technique and diet according to the developed training curriculum | Behavioural | Intensive training group |
Primary outcome
Exit site infection
Time frame: 24 months
23 secondary outcomes
time to the first peritonitis
Time frame: 24 months
Number of ESIs per patient-month
Time frame: 24 months
Days of hospitalization per year
Time frame: 24 months
Systolic pressure and diastolic pressure measured at every visit
Time frame: 24 months
Average number of antihypertensive medications
Time frame: 24 months
Kt/V
Time frame: 24 months
Residual renal function
Time frame: 24 months
Fluid balance score
Time frame: 24 months
Patient survival rate
Time frame: 24 months
Total medical cost
Time frame: 24 months
Total hours of education and training
Time frame: 24 months
Unplanned home visit and education by peritoneal dialysis nurse
Time frame: 24 months
Compliance score of patients
Time frame: 24 months
HbA1c only for patients with diabetes
Time frame: 24 months
Intact PTH level
Time frame: 24 months
Hemoglobin level
Time frame: 24 months
nPNA
Time frame: 24 months
QOL
Time frame: 24 months
SGA
Time frame: 24 months
K level
Time frame: 24 months
Total number of hospitalizations by cause over the last 1 and/or 2 years after the dialysis
Time frame: 24 months
Technical survival rate
Time frame: 24 months
peritonitis rate
Time frame: 24 months
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 14 Apr 2016.
- Individual participant dataSharing planned: No
Related trials for Risk Reduction
RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
Metastatic Melanoma
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Recruiting
A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer
Ovarian Carcinoma
Not yet recruiting
Reducing Exposure With Air Cleaners and Technology
Asthma, COPD (Chronic Obstructive Pulmonary Disease)
Active, not recruiting
Eat, Move, Live Program for the Reduction of Cancer and Chronic Disease Risk in Underserved Communities
Diabetes Mellitus, Obesity-Related Malignant Neoplasm
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.
Kook-Hwan Oh, M.D., PhD principal investigator
Seoul National University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive training group in people with Risk Reduction, run by Kook-Hwan Oh at 6 sites in South Korea.
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 2 inclusion and 9 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 14 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in South Korea. 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?
Exit site infection (time frame: 24 months). 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 14 Apr 2016.