Haemodialysis-induced SymptomNCT01620580
Symptom Management Program for Hemodialysis Patients
A study testing Self-management and Dietary Information in people with Haemodialysis-induced Symptom, run by The University of Texas Health Science Center, Houston at 2 sites in United States.
Trial summary
Self-management intervention may decrease symptom burden and improve functioning over time. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Haemodialysis-induced Symptom
- What is being tested?
- Self-management and Dietary Information
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2011to May 2012
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age ≥ 18 years old,
- on HD three times a week,
- received HD for ≥ six months,
- read and write English,
- have telephone service.
Who cannot join
- history of dementia,
- acquired immunodeficiency syndrome (AIDS) and active cancer, and
- inability to give informed consent.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
DaVita Summit Dialysis
Houston, Texas, 77003
DaVita Houston Dialysis
Houston, Texas, 77011
About this study
Self-management intervention may decrease symptom burden and improve functioning over time.
Read the detailed description
Self-management intervention (strategies) may decrease symptom burden (sleep disturbance, tiredness; itching and numbness) and improve functioning (social, physical and emotional) over time(baseline, 3 weeks and 8 weeks).
- Conditions
- Haemodialysis-induced Symptom
- Being tested
- Self-management, Dietary Information
- Keywords
- sleep disturbance, tiredness, itching & numbness
- Medical subject headings
- Parasomnias, Fatigue, Pruritus, Hypesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-managementBehavioural
Also called Behavioral
Participants in the intervention group will receive printed self management strategies each of the 5 symptoms, a symptom diary with the self-management strategies and a 15 minutes discussion. The intervention script will instruct participants on how to use the printed strategies by PI and RA #1.
Week 3
Dietary InformationBehavioural
Also called Behavioral
The control or usual care group will receive a symptom diary designed for the control group without any strategies and a 5 minutes discussion on how to complete the diary from RA# 1. The PI will make weekly follow up calls on the same schedule as the intervention group starting week 4 until week 7 for a total of 4 calls focusing on enhancing healthy eating skills \& adherence to renal diet and fluid restriction without discussing any intervention with the group.
| Study group | Role | What they receive |
|---|---|---|
| Self Management Strategies | Active comparator | Participants in the intervention group will receive printed self management strategies each of the 5 symptoms, a symptom diary with the self-management strategies and a 15 minutes discussion. The intervention script will instruct participants on how to use the printed strategies by PI and RA #1.
Week 3. Receives: Behavioral: Self-management |
| Dietary Information | Active comparator | Control arm Receives: Behavioral: Dietary Information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease symptom burden
The study aims are:
- To compare the differences between the self management intervention and control group on the following outcomes:
- Decreased symptoms: itching, tiredness, numbness, sleep disturbance (difficulty falling asleep \& difficulty staying asleep);
- Adherence to treatment diary Improved social functioning, physical functioning and emotional status.
Measured: 8 weeks
Secondary outcomes (1)
Feasibility of implementing self management intervention
To evaluate the feasibility of implementing the self management intervention for a larger randomized controlled studyTreatment delivered (number of interventions sessions delivered and strategies used); Treatment receipts (understanding of strategies); and Treatment enactment (reported perception of usefulness of the strategies).
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2012 (estimated)
- Study startSep 2011
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Haemodialysis-induced SymptomStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francess Danquah, The University of Texas Health Science Center, Houston
- Investigators
- Francess V Danquah, PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01620580
- Sponsor's protocol ID
- HSC-SN-11-0465
- Status last verified
- Jun 2012
- First submitted
- 24 Oct 2011
- Last updated
- 15 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Dodd M, Janson S, Facione N, Faucett J, Froelicher ES, Humphreys J, Lee K, Miaskowski C, Puntillo K, Rankin S, Taylor D. Advancing the science of symptom management. J Adv Nurs. 2001 Mar;33(5):668-76. doi: 10.1046/j.1365-2648.2001.01697.x.
PubMed 11298204Natale P, Ju A, Strippoli GF, Craig JC, Saglimbene VM, Unruh ML, Stallone G, Jaure A. Interventions for fatigue in people with kidney failure requiring dialysis. Cochrane Database Syst Rev. 2023 Aug 31;8(8):CD013074. doi: 10.1002/14651858.CD013074.pub2.
PubMed 37651553Hercz D, Jiang SH, Webster AC. Interventions for itch in people with advanced chronic kidney disease. Cochrane Database Syst Rev. 2020 Dec 7;12(12):CD011393. doi: 10.1002/14651858.CD011393.pub2.
PubMed 33283264
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Symptom Management Program for Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT01620580
- Acronym / sponsor ID
- HSC-SN-11-0465
- Conditions
- Haemodialysis-induced Symptom
- Keywords
- sleep disturbance, tiredness, itching & numbness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 15 Jun 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.
Self-management intervention may decrease symptom burden and improve functioning over time.
Detailed description
Self-management intervention (strategies) may decrease symptom burden (sleep disturbance, tiredness; itching and numbness) and improve functioning (social, physical and emotional) over time(baseline, 3 weeks and 8 weeks).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self Management Strategies | Active comparator | Behavioral: Self-managementParticipants in the intervention group will receive printed self management strategies each of the 5 symptoms, a symptom diary with the self-management strategies and a 15 minutes discussion. The intervention script will instruct participants on how to use the printed strategies by PI and RA #1. Week 3. |
| Dietary Information | Active comparator | Behavioral: Dietary InformationControl arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age ≥ 18 years old,
- on HD three times a week,
- received HD for ≥ six months,
- read and write English,
- have telephone service.
Key exclusion criteria (3 listed)
- history of dementia,
- acquired immunodeficiency syndrome (AIDS) and active cancer, and
- inability to give informed consent.
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 |
|---|---|---|
| Self-managementAlso: BehavioralParticipants in the intervention group will receive printed self management strategies each of the 5 symptoms, a symptom diary with the self-management strategies and a 15 minutes discussion. The intervention script will instruct participants on how to use the printed strategies by PI and RA #1. Week 3 | Behavioural | Self Management Strategies |
| Dietary InformationAlso: BehavioralThe control or usual care group will receive a symptom diary designed for the control group without any strategies and a 5 minutes discussion on how to complete the diary from RA# 1. The PI will make weekly follow up calls on the same schedule as the intervention group starting week 4 until week 7 for a total of 4 calls focusing on enhancing healthy eating skills \& adherence to renal diet and fluid restriction without discussing any intervention with the group. | Behavioural | Dietary Information |
Primary outcome
Decrease symptom burden
Time frame: 8 weeks
The study aims are: 1. To compare the differences between the self management intervention and control group on the following outcomes: 1. Decreased symptoms: itching, tiredness, numbness, sleep disturbance (difficulty falling asleep \& difficulty staying asleep); 2. Adherence to treatment diary Improved social functioning, physical functioning and emotional status.
1 secondary outcome
Feasibility of implementing self management intervention
Time frame: 5 weeks
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 15 Jun 2012.
- Background: PubMed 11298204Dodd M, Janson S, Facione N, Faucett J, Froelicher ES, Humphreys J, Lee K, Miaskowski C, Puntillo K, Rankin S, Taylor D. Advancing the science of symptom management. J Adv Nurs. 2001 Mar;33(5):668-76. doi: 10.1046/j.1365-2648.2001.01697.x.
- Derived from this study: PubMed 37651553Natale P, Ju A, Strippoli GF, Craig JC, Saglimbene VM, Unruh ML, Stallone G, Jaure A. Interventions for fatigue in people with kidney failure requiring dialysis. Cochrane Database Syst Rev. 2023 Aug 31;8(8):CD013074. doi: 10.1002/14651858.CD013074.pub2.
- Derived from this study: PubMed 33283264Hercz D, Jiang SH, Webster AC. Interventions for itch in people with advanced chronic kidney disease. Cochrane Database Syst Rev. 2020 Dec 7;12(12):CD011393. doi: 10.1002/14651858.CD011393.pub2.
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ULtrafiltration-Rate Induced CArdiac Strain (ULRICA) - Study
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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.
Francess V Danquah, PhD principal investigator
The University of Texas Health Science Center, Houston
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-management and Dietary Information in people with Haemodialysis-induced Symptom, run by The University of Texas Health Science Center, Houston at 2 sites in United States.
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 5 inclusion and 3 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 15 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Decrease symptom burden (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01620580, which also lists 3 linked publications.
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 Jun 2012.