End Stage Renal Disease Requiring HemodialysisNCT02130089
Can Dietitians Reduce Interdialytic Weight Gain in at Risk Hemodialysis Patients Through Tailored Education on Dietary Sodium and Fluid Intake?
A study testing Intensive Tailored Education in people with End Stage Renal Disease Requiring Hemodialysis, run by Academy of Nutrition and Dietetics at 1 site in New Zealand.
Trial summary
The purpose of this project is to understand if more frequent education of dialysis patients (patients with kidney failure who get their blood cleaned and fluid removed by a machine instead of their kidneys) on reducing sodium intake reduces the amount of fluid weight that patients gain between dialysis sessions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease Requiring Hemodialysis
- What is being tested?
- Intensive Tailored Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteNew Zealand
- Study dates
- Apr 2014to Nov 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Average Interdialytic weight gain (IDWG) for 2 weeks prior to screening period greater than or equal to 4% estimated dry weight
- Able to sign the locally approved informed consent
- Willing to receive dietitian education on sodium and fluid control during normal dialysis time
- Receiving thrice weekly maintenance hemodialysis for greater than or equal to 6 months Age greater than or equal to 18 years
Who cannot join
- On hospice or international equivalent
- Receiving corticosteroid treatment
- Less than 18 years old
- On interdialytic parenteral nutrition
- Transfer to another facility expected within 3 months
- Severe malnutrition, as assessed by Subjective Global Assessment (SGA) or other standard assessment tool
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this project is to understand if more frequent education of dialysis patients (patients with kidney failure who get their blood cleaned and fluid removed by a machine instead of their kidneys) on reducing sodium intake reduces the amount of fluid weight that patients gain between dialysis sessions. Patients who usually gain more fluid than is considered ideal will be recruited for this project. Because all patients gain different amounts to start, data will be collected for 3 months while the patients receive their usual amount of dietitian education. Then the patients will receive intensive (2x/month) education on reducing sodium intake from the dietitian and the same data will be collected to see if they gain less after the education. After 3 months of intensive education, data will be collected for one more month to see if patients keep gaining less or if they go back to their old patterns.
- Being tested
- Intensive Tailored Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive Tailored EducationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| All patients | Other | Intensive tailored education Receives: Behavioral: Intensive Tailored Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Percent Interdialytic Weight Gain
Measured: monthly for 7 months
Secondary outcomes (2)
Thirst Intensity
will be measured by a 100 mm Visual Analog Scale. Patients are asked to mark the point on the VAS which represents their work thirst since the last dialysis. Zero is considered no thirst and 100 is extremely thirsty. This tool has been shown to correlate to the Thirst Distress tool developed by Welsh in 2002.
Measured: monthly for 7 months
Sodium and Fluid Knowledge
Will be assessed using the sodium questions of the tool created by Kim (Korean J Nutr 2001), as modified by Park (J Ren Nutr 2008).
Measured: Monthly for 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2014 (estimated)
- Study startApr 2014
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal Disease Requiring HemodialysisStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Academy of Nutrition and Dietetics
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alison Steiber, Academy of Nutrition and Dietetics
- Investigators
- Sandra McLellan, Principal investigator, Auckland Board of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02130089
- Sponsor's protocol ID
- 13-186
- Status last verified
- Jan 2016
- First submitted
- 28 Apr 2014
- Last updated
- 27 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Dietitians Reduce Interdialytic Weight Gain in at Risk Hemodialysis Patients Through Tailored Education on Dietary Sodium and Fluid Intake?
- ClinicalTrials.gov ID
- NCT02130089
- Acronym / sponsor ID
- 13-186
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Academy of Nutrition and DieteticsUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 5 May 2014 (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.
The purpose of this project is to understand if more frequent education of dialysis patients (patients with kidney failure who get their blood cleaned and fluid removed by a machine instead of their kidneys) on reducing sodium intake reduces the amount of fluid weight that patients gain between dialysis sessions. Patients who usually gain more fluid than is considered ideal will be recruited for this project. Because all patients gain different amounts to start, data will be collected for 3 months while the patients receive their usual amount of dietitian education. Then the patients will receive intensive (2x/month) education on reducing sodium intake from the dietitian and the same data will be collected to see if they gain less after the education. After 3 months of intensive education, data will be collected for one more month to see if patients keep gaining less or if they go back to their old patterns.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | Other | Behavioral: Intensive Tailored EducationIntensive tailored education |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Average Interdialytic weight gain (IDWG) for 2 weeks prior to screening period greater than or equal to 4% estimated dry weight
- Able to sign the locally approved informed consent
- Willing to receive dietitian education on sodium and fluid control during normal dialysis time
- Receiving thrice weekly maintenance hemodialysis for greater than or equal to 6 months Age greater than or equal to 18 years
Key exclusion criteria (6 listed)
- On hospice or international equivalent
- Receiving corticosteroid treatment
- Less than 18 years old
- On interdialytic parenteral nutrition
- Transfer to another facility expected within 3 months
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 Tailored Education | Behavioural | All patients |
Primary outcome
Average Percent Interdialytic Weight Gain
Time frame: monthly for 7 months
2 secondary outcomes
Thirst Intensity
Time frame: monthly for 7 months
Sodium and Fluid Knowledge
Time frame: Monthly for 4 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 27 Jan 2016.
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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.
Sandra McLellan principal investigator
Auckland Board of Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive Tailored Education in people with End Stage Renal Disease Requiring Hemodialysis, run by Academy of Nutrition and Dietetics at 1 site in New Zealand.
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 4 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 27 Jan 2016. 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 New Zealand. 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?
Average Percent Interdialytic Weight Gain (time frame: monthly for 7 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 27 Jan 2016.