Stage 5 Chronic Kidney DiseasePhase 2/3NCT01509690
Impact of a Multidisciplinary Intensive Management Clinic on Outcomes in Multi-Ethnic Asian Incident Hemodialysis Patients
A Phase 2/3 study testing Multidisciplinary, intensive and collaborative care in people with Stage 5 Chronic Kidney Disease, run by National University of Singapore at 1 site in Singapore.
Trial summary
Patients with end-stage renal disease are most vulnerable in the early months following hemodialysis (HD) initiation. Data from the United States Renal Data System and Singapore Renal Registry showed high mortality rates in the first 3-12 months of dialysis. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Stage 5 Chronic Kidney Disease
- What is being tested?
- Multidisciplinary, intensive and collaborative care
- Type of treatment
- Vaccines
- How many people
- 150 participants
- Where
- 1 siteSingapore
- Study dates
- Start not givento not given
- Phase
- Phase 2/3
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all patients who are newly-initiated on HD and who meet the following criteria will be included in the study:
- male or female 21 years of age or older with stage 5 CKD (eGFR < 15 ml/min/1.73m2)
- newly-initiated on HD within the past 4-8 weeks of being seen in the NUH outpatient renal clinic
Who cannot join
- transient HD patients
- patients with poor cognitive function or are not able to complete the PRO questionnaires.
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
National University Hospital
Singapore, Singapore
Priscilla P How, Pharm.D., BCPS, (65)6516-4906
Priscilla P How, Pharm.D., BCPS
About this study
Official title: Impact of a Multidisciplinary Intensive Management Clinic on Clinical, Patient-Reported and Economic Outcomes in Multi-Ethnic Asian Incident Hemodialysis Patients
Patients with end-stage renal disease are most vulnerable in the early months following hemodialysis (HD) initiation. Data from the United States Renal Data System and Singapore Renal Registry showed high mortality rates in the first 3-12 months of dialysis. Comprehensive multidisciplinary intervention programs implemented in the initial 3-4 months of dialysis showed reduction in mortality and morbidity in incident dialysis patients in the United States.
Based on these models, the Hemodialysis Initiation and Transition (HIT) Clinic involving a renal physician, clinical pharmacist and coordinator was set up. The main aim of the clinic is to provide multidisciplinary, intensive and consistent care to patients in the first 3 to 4 months after HD initiation to focus on and streamline the management of dialysis issues and complications. These interventions would help patients achieve goal therapeutic targets, as well as reduce hospitalization rates and mortality, thereby improving their clinical outcomes and self-reported quality of life, and could result in economic and cost savings for the patients and healthcare system. The purpose of this study is to determine if the multidisciplinary, intensive and collaborative management of our multiethnic Asian patients newly-initiated on HD improves laboratory, clinical, economic and patient-reported outcomes.
Adult incident HD patients from NUH will be randomized to the HIT clinic or to conventional management. Information on demographics, medical/medication histories, laboratory data (dialysis adequacy, iron-deficiency anemia, mineral/bone disorder, malnutrition and diabetes), hospitalizations, deaths and medical costs will be obtained and compared between the 2 groups. Patient-reported outcomes will be measured using the Kidney Disease Quality of Life-Short Form, EuroQol 5 Dimensions, Family Functioning Measure, Oslo-3 Social Support Scale and Health Services Utilization questionnaires. Data collection will take place at baseline, 3 to 4 months and 12 months after the first visit, with a total study duration and follow-up period of 1 year.
- Conditions
- Stage 5 Chronic Kidney Disease
- Being tested
- Multidisciplinary, intensive and collaborative care
- Keywords
- Incident, Hemodialysis
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidisciplinary, intensive and collaborative careOther
Also called No specific study drugs, devices or procedures are involved
No specific study drugs, devices or procedures are involved.
Subjects will be seen in a multidisciplinary, intensive management clinic involving a renal physician, a clinical pharmacist trained in renal pharmacotherapy and a renal coordinator. The main aim of this clinic is to provide multidisciplinary, intensive and consistent care in the first 3 to 4 months after HD initiation to streamline the management of the patients. Specific objectives of this clinic include providing patients with educational materials and information to enable a better understanding of their disease process, providing uniform anemia and renal bone disease management, increasing permanent HD access [arteriovenous (AV) fistula or graft] placement, increasing transplant referrals, providing suitable vaccinations to all patients, as well as reducing hospitalizations for fluid overload, uncontrolled hypertension and anemia-related complications.
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical (mortality and morbidity)
Mortality and morbidity (hospitalization from uncontrolled hypertension, anemia and fluid overload)
Measured: One year
Secondary outcomes (3)
Laboratory outcomes
Lab results
Measured: One year
Economic outcomes
Direct and indirect medical costs
Measured: One year
Patient-reported outcomes
KDQOL and other social support questionnaires
Measured: One-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage 5 Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by National University of SingaporeThe 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 2/3
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Priscilla How, Pharm.D., BCPS, National University of Singapore
- Investigators
- Priscilla P How, Pharm.D., BCPS, Principal investigator, National University of Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01509690
- Sponsor's protocol ID
- DSRB Domain E/2011/1772
- Status last verified
- Apr 2015
- First submitted
- 6 Jan 2012
- Last updated
- 15 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Multidisciplinary Intensive Management Clinic on Clinical, Patient-Reported and Economic Outcomes in Multi-Ethnic Asian Incident Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT01509690
- Acronym / sponsor ID
- DSRB Domain E/2011/1772
- Conditions
- Stage 5 Chronic Kidney Disease
- Keywords
- Incident, Hemodialysis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- National University of SingaporeUniversity, hospital or other
- First posted
- 13 Jan 2012 (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.
Patients with end-stage renal disease are most vulnerable in the early months following hemodialysis (HD) initiation. Data from the United States Renal Data System and Singapore Renal Registry showed high mortality rates in the first 3-12 months of dialysis. Comprehensive multidisciplinary intervention programs implemented in the initial 3-4 months of dialysis showed reduction in mortality and morbidity in incident dialysis patients in the United States.
Based on these models, the Hemodialysis Initiation and Transition (HIT) Clinic involving a renal physician, clinical pharmacist and coordinator was set up. The main aim of the clinic is to provide multidisciplinary, intensive and consistent care to patients in the first 3 to 4 months after HD initiation to focus on and streamline the management of dialysis issues and complications. These interventions would help patients achieve goal therapeutic targets, as well as reduce hospitalization rates and mortality, thereby improving their clinical outcomes and self-reported quality of life, and could result in economic and cost savings for the patients and healthcare system. The purpose of this study is to determine if the multidisciplinary, intensive and collaborative management of our multiethnic Asian patients newly-initiated on HD improves laboratory, clinical, economic and patient-reported outcomes.
Adult incident HD patients from NUH will be randomized to the HIT clinic or to conventional management. Information on demographics, medical/medication histories, laboratory data (dialysis adequacy, iron-deficiency anemia, mineral/bone disorder, malnutrition and diabetes), hospitalizations, deaths and medical costs will be obtained and compared between the 2 groups. Patient-reported outcomes will be measured using the Kidney Disease Quality of Life-Short Form, EuroQol 5 Dimensions, Family Functioning Measure, Oslo-3 Social Support Scale and Health Services Utilization questionnaires. Data collection will take place at baseline, 3 to 4 months and 12 months after the first visit, with a total study duration and follow-up period of 1 year.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- all patients who are newly-initiated on HD and who meet the following criteria will be included in the study:
- male or female 21 years of age or older with stage 5 CKD (eGFR < 15 ml/min/1.73m2)
- newly-initiated on HD within the past 4-8 weeks of being seen in the NUH outpatient renal clinic
Key exclusion criteria (2 listed)
- transient HD patients
- patients with poor cognitive function or are not able to complete the PRO questionnaires.
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 |
|---|---|---|
| Multidisciplinary, intensive and collaborative careAlso: No specific study drugs, devices or procedures are involvedNo specific study drugs, devices or procedures are involved. Subjects will be seen in a multidisciplinary, intensive management clinic involving a renal physician, a clinical pharmacist trained in renal pharmacotherapy and a renal coordinator. The main aim of this clinic is to provide multidisciplinary, intensive and consistent care in the first 3 to 4 months after HD initiation to streamline the management of the patients. Specific objectives of this clinic include providing patients with educational materials and information to enable a better understanding of their disease process, providing uniform anemia and renal bone disease management, increasing permanent HD access [arteriovenous (AV) fistula or graft] placement, increasing transplant referrals, providing suitable vaccinations to all patients, as well as reducing hospitalizations for fluid overload, uncontrolled hypertension and anemia-related complications. | Other | – |
Primary outcome
Clinical (mortality and morbidity)
Time frame: One year
Mortality and morbidity (hospitalization from uncontrolled hypertension, anemia and fluid overload)
3 secondary outcomes
Laboratory outcomes
Time frame: One year
Economic outcomes
Time frame: One year
Patient-reported outcomes
Time frame: One-year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2015.
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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.
Priscilla P How, Pharm.D., BCPS principal investigator
National University of Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Multidisciplinary, intensive and collaborative care in people with Stage 5 Chronic Kidney Disease, run by National University of Singapore at 1 site in Singapore.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 15 Apr 2015. 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 Singapore. 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.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Priscilla P How, Pharm.D., BCPS (65-516-4906, priscillahow@nus.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical (mortality and morbidity) (time frame: One year). 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 15 Apr 2015.