Hemodialysis ComplicationNCT05466773
Hemodialysis Eating Education Intervention in Hemodialysis Patients
A study testing Hemodialysis eating index (HDEI) base education intervention in people with Hemodialysis Complication, run by Taipei Medical University at 1 site in Taiwan.
Trial summary
The investigator aim to evaluate the effect of training program on treatment adherence, quality of life, cardiovascular risk factors, depression, and healthcare utilization. The investigator conducted a quasi experimental study. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Hemodialysis Complication
- What is being tested?
- Hemodialysis eating index (HDEI) base education intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 May 2019to 30 Jun 2022
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hemodialysis patients whose aged 20-75 years, received hemodialysis treatment thrice a week for at least 3 months, the education level of junior high school and higher, and Kt/V > 1.2.
Who cannot join
- Hemodialysis patients with obvious edema, pregnancy, amputation, hyperthyroidism, hypothyroidism, malignancy, liver failure or cancer, mental disorders, tube feeding, hospitalization and plan to surgery, loss to measure body composition, and percentage body fat < 4% were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hemodialysis Eating Education Intervention to Improve the Depression, Treatment Adherence, Cardiovascular Risks, Quality of Life, and Healthcare Utilization Among Hemodialysis Patients: A Quasi-experimental Design
The investigator aim to evaluate the effect of training program on treatment adherence, quality of life, cardiovascular risk factors, depression, and healthcare utilization. The investigator conducted a quasi experimental study. The investigator also examine the effect of interaction between health literacy and training program on depression, treatment adherence, cardiovascular risk factors, quality of life, and healthcare utilization.
The ultimate goal is to improve the dietary intake and dialysis outcomes for all hemodialysis patients in Taiwan. The investigator therefore will the SaaS dietary educational platform for this purpose.
Read the detailed description
The investigator have completed the surveys on dietary intake, anthropometrics, clinical assessments, body compositions, and biochemical parameters and so on in designed hospitals. Assessment of cardiovascular disease risk factors: The diagnosed values were defined by the National Kidney Foundation Kidney Disease Outcomes Quality Initiative Work Group.
Health Literacy Health literacy will be also measured by Chew's 3 brief health literacy screening questions (BHLS), each with 5 possible response options [1]: (1) "How often do participants have problems learning about participants' medical condition because of difficulty understanding written information?" (always, often, sometimes, occasionally, or never); (2) "How often do participants have someone help participants read hospital materials?" (always, often, sometimes, occasionally, or never); and (3) "How confident are participants filling out medical forms by participants self?" (extremely, quite a bit, somewhat, a little bit, or not at all). The BHLS demonstrated evidence of construct validity among hemodialysis patients [2]. To identify the level of health literacy, sum scale of 3 screening questions will be calculate and classify into 3 levels: (1) Limited health literacy (=< 6 scale); (2) Marginal health literacy (7-8 scale); (3) Adequate health literacy (>= 9 scale) on the scale of 15 scale [3].
Dietary knowledge The dietary knowledge of nurses and patients will be evaluated pre-intervention and post-intervention, using a 10-item questionnaire developed by Kim and colleague [4]. The tool is to measure knowledge on protein, potassium, phosphorus, sodium, and water. The correct answer was treated as 'correct', incorrect or 'do not know' answers were treated as 'incorrect'; the highest scale possible was 10 points.
Treatment adherence Biological markers: The bio-markers to identify the dietary adherence are serum potassium (Pre-dialytic serum potassium ≤ 5.5 mEq/L), and phosphorus (Pre-dialytic serum phosphorus ≤ 4.5 mg/dL); fluid adherence is inter-dialysis weight gain (IDWG ≤ 4% of dry weight gain); medication adherence are (phosphate binders, antihypertensive, calcium supplements, and vitamin).
Self-report: The subjective adherence will be measured using the adherence behaviors subscale of the ESRD-Adherence Questionnaire (ESRD-AQ) [6]. The four subscales will be used which ask about treatment adherence to hemodialysis treatment (item 14 "During the last month, how many dialysis treatments did participants miss completely?", 17 "During the last month, how many times have participants shortened participants' dialysis time?", and 18 "During the last month, when participants' dialysis treatment was shortened, what was the average number of minutes?"), medications (item 26 "During the past week, how often have participants missed participants' prescribed medicines?"), fluid restrictions (item 31 "During the past week, how often have participants followed the fluid restriction recommendations?"), and diet recommendations (item 46 "During the past week, how many times have participants followed the diet recommendations?"). The ESRD-AQ is designed with the 5-point Likert scale, such that higher scales indicate better adherence.
Mental health The mental health was assessed by the Center for Epidemiologic Studies Short Depression Scale (CES-D 10). Patient will be asked about the ways they may have felt or behaved during the past week on the scale from rarely or none of the time to all of the time. Scale is the sum of the points for all 10 items. If more than 2 items are missing, do not scale. A scale of 10 or greater is considered depressed.
Quality of Life The quality of life among hemodialysis patients will be assessed using the Short Form-12 health survey subscale of the Kidney Disease and Quality of Life (KDQOL), with items measuring general health, activity limits (physical functioning), ability to accomplish desired tasks (role physical), role emotional, emotional well-being, energy level, pain, and social activities [7]. The SF-12 scale was validated in hemodialysis patients in Chinese population [8, 9].
Healthcare utilization Frequency of usage of emergency services, end-stage renal disease (ESRD)-related hospitalizations over past 6 months.
Patients' characteristics and health related behaviors Age (year), gender (male/female), marital status (married, single, divorce, widowed), highest education attainment (elementary school, junior high school, senior high school, college/university and above), ability to pay for medication (very difficult, fairly difficult, fairly easy, very easy), self-assessed social status (low, middle, high).
The physical activity was assessed by using valid and reliable Chinese version of the international physical activity questionnaire short form (IPAQ-SF) [10-12]. This 7-item survey aims to identify the frequency and duration of vigorous, moderate, and light PA, as well as inactivity during the past one week. Patients will be asked about frequency and amount of alcoholic beverage drinking in the last 30 days, and smoking status (non-smoker, occasional smoker, smoker).
- Conditions
- Hemodialysis Complication
- Being tested
- Hemodialysis eating index (HDEI) base education intervention
- Keywords
- hemodialysis, nutrition education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemodialysis eating index (HDEI) base education interventionBehavioural
The investigators have developed the educational materials for patients, in order to improve the dialysis outcomes. The interventions will be delivered to patients and nurses in hospital based hemodialysis centers.
| Study group | Role | What they receive |
|---|---|---|
| CN group | Experimental | Giving nutrition education for nurse, but not for patients Receives: Behavioral: Hemodialysis eating index (HDEI) base education intervention |
| CP group | Experimental | Giving nutrition education for patients, but not for nurses Receives: Behavioral: Hemodialysis eating index (HDEI) base education intervention |
| CNP group | Experimental | Giving nutrition education for both patients and nurses Receives: Behavioral: Hemodialysis eating index (HDEI) base education intervention |
| NC group | No intervention | No nutrition education for patients and nurses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Literacy
Health literacy will be also measured by Chew's 3 brief health literacy screening questions (BHLS), each with 5 possible response options: (1) "How often do you have problems learning about your medical condition because of difficulty understanding written information?" (always, often, sometimes, occasionally, or never); (2) "How often do you have someone help you read hospital materials?" (always, often, sometimes, occasionally, or never); and (3) "How confident are you filling out medical forms by yourself?" (extremely, quite a bit, somewhat, a little bit, or not at all).
Measured: baseline
Secondary outcomes (1)
Dietary knowledge
The dietary knowledge of nurses and patients will be evaluated pre-intervention and post-intervention, using a 10-item questionnaire developed by Kim and colleague. The tool is to measure knowledge on protein, potassium, phosphorus, sodium, and water. The correct answer was treated as 'correct', incorrect or 'do not know' answers were treated as 'incorrect'; the highest scale possible was 10 points.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start1 May 2019
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Hemodialysis ComplicationStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- quasi-experimental design with 4 groups
- Masking
- None (open label)
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Taipei Medical University Hospital, Cathay General Hospital, Taipei Medical University WanFang Hospital, Taipei Medical University Shuang Ho Hospital
- Responsible party
- Principal investigator, Shwu-Huey Yang, Taipei Medical University
- Investigators
- Shwu-Huey Yang, Ph.D, Principal investigator, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05466773
- Sponsor's protocol ID
- TMU-JIRB：N201801034
- Status last verified
- Jul 2022
- First submitted
- 14 Jul 2022
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We need more time to clear the data.
Publications
Chew LD, Bradley KA, Boyko EJ. Brief questions to identify patients with inadequate health literacy. Fam Med. 2004 Sep;36(8):588-94.
PubMed 15343421Cavanaugh KL, Osborn CY, Tentori F, Rothman RL, Ikizler TA, Wallston KA. Performance of a brief survey to assess health literacy in patients receiving hemodialysis. Clin Kidney J. 2015 Aug;8(4):462-8. doi: 10.1093/ckj/sfv037. Epub 2015 Jun 10.
PubMed 26251719Wallace LS, Rogers ES, Roskos SE, Holiday DB, Weiss BD. Brief report: screening items to identify patients with limited health literacy skills. J Gen Intern Med. 2006 Aug;21(8):874-7. doi: 10.1111/j.1525-1497.2006.00532.x.
PubMed 16881950Duff EA, Chawke FM. A service review to assess if innovative intensive phosphate dietary education can help reduce phosphate levels to the recommended range in a hemodialysis population. Hemodial Int. 2017 Oct;21 Suppl 2:S22-S26. doi: 10.1111/hdi.12593.
PubMed 29064180Kim Y, Evangelista LS, Phillips LR, Pavlish C, Kopple JD. The End-Stage Renal Disease Adherence Questionnaire (ESRD-AQ): testing the psychometric properties in patients receiving in-center hemodialysis. Nephrol Nurs J. 2010 Jul-Aug;37(4):377-93.
PubMed 20830945Hays RD, Kallich JD, Mapes DL, Coons SJ, Carter WB. Development of the kidney disease quality of life (KDQOL) instrument. Qual Life Res. 1994 Oct;3(5):329-38. doi: 10.1007/BF00451725.
PubMed 7841967Wan EY, Chen JY, Choi EP, Wong CK, Chan AK, Chan KH, Lam CL. Patterns of health-related quality of life and associated factors in Chinese patients undergoing haemodialysis. Health Qual Life Outcomes. 2015 Jul 29;13:108. doi: 10.1186/s12955-015-0308-3.
PubMed 26215978Joshi VD, Mooppil N, Lim JF. Validation of the kidney disease quality of life-short form: a cross-sectional study of a dialysis-targeted health measure in Singapore. BMC Nephrol. 2010 Dec 20;11:36. doi: 10.1186/1471-2369-11-36.
PubMed 21172008Macfarlane DJ, Lee CC, Ho EY, Chan KL, Chan DT. Reliability and validity of the Chinese version of IPAQ (short, last 7 days). J Sci Med Sport. 2007 Feb;10(1):45-51. doi: 10.1016/j.jsams.2006.05.003. Epub 2006 Jun 30.
PubMed 16807105Liou YM, Jwo CJ, Yao KG, Chiang LC, Huang LH. Selection of appropriate Chinese terms to represent intensity and types of physical activity terms for use in the Taiwan version of IPAQ. J Nurs Res. 2008 Dec;16(4):252-63. doi: 10.1097/01.jnr.0000387313.20386.0a.
PubMed 19061172
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodialysis Eating Education Intervention to Improve the Depression, Treatment Adherence, Cardiovascular Risks, Quality of Life, and Healthcare Utilization Among Hemodialysis Patients: A Quasi-experimental Design
- ClinicalTrials.gov ID
- NCT05466773
- Acronym / sponsor ID
- TMU-JIRB：N201801034
- Conditions
- Hemodialysis Complication
- Keywords
- hemodialysis, nutrition education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Collaborators
- Taipei Medical University Hospital, Cathay General Hospital, Taipei Medical University WanFang Hospital, Taipei Medical University Shuang Ho Hospital
- Study start
- 1 May 2019 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 20 Jul 2022 (actual)
- 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 investigator aim to evaluate the effect of training program on treatment adherence, quality of life, cardiovascular risk factors, depression, and healthcare utilization. The investigator conducted a quasi experimental study. The investigator also examine the effect of interaction between health literacy and training program on depression, treatment adherence, cardiovascular risk factors, quality of life, and healthcare utilization.
The ultimate goal is to improve the dietary intake and dialysis outcomes for all hemodialysis patients in Taiwan. The investigator therefore will the SaaS dietary educational platform for this purpose.
Detailed description
The investigator have completed the surveys on dietary intake, anthropometrics, clinical assessments, body compositions, and biochemical parameters and so on in designed hospitals. Assessment of cardiovascular disease risk factors: The diagnosed values were defined by the National Kidney Foundation Kidney Disease Outcomes Quality Initiative Work Group.
Health Literacy Health literacy will be also measured by Chew's 3 brief health literacy screening questions (BHLS), each with 5 possible response options [1]: (1) "How often do participants have problems learning about participants' medical condition because of difficulty understanding written information?" (always, often, sometimes, occasionally, or never); (2) "How often do participants have someone help participants read hospital materials?" (always, often, sometimes, occasionally, or never); and (3) "How confident are participants filling out medical forms by participants self?" (extremely, quite a bit, somewhat, a little bit, or not at all). The BHLS demonstrated evidence of construct validity among hemodialysis patients [2]. To identify the level of health literacy, sum scale of 3 screening questions will be calculate and classify into 3 levels: (1) Limited health literacy (=< 6 scale); (2) Marginal health literacy (7-8 scale); (3) Adequate health literacy (>= 9 scale) on the scale of 15 scale [3].
Dietary knowledge The dietary knowledge of nurses and patients will be evaluated pre-intervention and post-intervention, using a 10-item questionnaire developed by Kim and colleague [4]. The tool is to measure knowledge on protein, potassium, phosphorus, sodium, and water. The correct answer was treated as 'correct', incorrect or 'do not know' answers were treated as 'incorrect'; the highest scale possible was 10 points.
Treatment adherence Biological markers: The bio-markers to identify the dietary adherence are serum potassium (Pre-dialytic serum potassium ≤ 5.5 mEq/L), and phosphorus (Pre-dialytic serum phosphorus ≤ 4.5 mg/dL); fluid adherence is inter-dialysis weight gain (IDWG ≤ 4% of dry weight gain); medication adherence are (phosphate binders, antihypertensive, calcium supplements, and vitamin).
Self-report: The subjective adherence will be measured using the adherence behaviors subscale of the ESRD-Adherence Questionnaire (ESRD-AQ) [6]. The four subscales will be used which ask about treatment adherence to hemodialysis treatment (item 14 "During the last month, how many dialysis treatments did participants miss completely?", 17 "During the last month, how many times have participants shortened participants' dialysis time?", and 18 "During the last month, when participants' dialysis treatment was shortened, what was the average number of minutes?"), medications (item 26 "During the past week, how often have participants missed participants' prescribed medicines?"), fluid restrictions (item 31 "During the past week, how often have participants followed the fluid restriction recommendations?"), and diet recommendations (item 46 "During the past week, how many times have participants followed the diet recommendations?"). The ESRD-AQ is designed with the 5-point Likert scale, such that higher scales indicate better adherence.
Mental health The mental health was assessed by the Center for Epidemiologic Studies Short Depression Scale (CES-D 10). Patient will be asked about the ways they may have felt or behaved during the past week on the scale from rarely or none of the time to all of the time. Scale is the sum of the points for all 10 items. If more than 2 items are missing, do not scale. A scale of 10 or greater is considered depressed.
Quality of Life The quality of life among hemodialysis patients will be assessed using the Short Form-12 health survey subscale of the Kidney Disease and Quality of Life (KDQOL), with items measuring general health, activity limits (physical functioning), ability to accomplish desired tasks (role physical), role emotional, emotional well-being, energy level, pain, and social activities [7]. The SF-12 scale was validated in hemodialysis patients in Chinese population [8, 9].
Healthcare utilization Frequency of usage of emergency services, end-stage renal disease (ESRD)-related hospitalizations over past 6 months.
Patients' characteristics and health related behaviors Age (year), gender (male/female), marital status (married, single, divorce, widowed), highest education attainment (elementary school, junior high school, senior high school, college/university and above), ability to pay for medication (very difficult, fairly difficult, fairly easy, very easy), self-assessed social status (low, middle, high).
The physical activity was assessed by using valid and reliable Chinese version of the international physical activity questionnaire short form (IPAQ-SF) [10-12]. This 7-item survey aims to identify the frequency and duration of vigorous, moderate, and light PA, as well as inactivity during the past one week. Patients will be asked about frequency and amount of alcoholic beverage drinking in the last 30 days, and smoking status (non-smoker, occasional smoker, smoker).
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- quasi-experimental design with 4 groups
| Arm | Type | Receives |
|---|---|---|
| CN group | Experimental | Behavioral: Hemodialysis eating index (HDEI) base education interventionGiving nutrition education for nurse, but not for patients |
| CP group | Experimental | Behavioral: Hemodialysis eating index (HDEI) base education interventionGiving nutrition education for patients, but not for nurses |
| CNP group | Experimental | Behavioral: Hemodialysis eating index (HDEI) base education interventionGiving nutrition education for both patients and nurses |
| NC group | No intervention | –No nutrition education for patients and nurses |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Hemodialysis patients whose aged 20-75 years, received hemodialysis treatment thrice a week for at least 3 months, the education level of junior high school and higher, and Kt/V > 1.2.
Key exclusion criteria (1 listed)
- Hemodialysis patients with obvious edema, pregnancy, amputation, hyperthyroidism, hypothyroidism, malignancy, liver failure or cancer, mental disorders, tube feeding, hospitalization and plan to surgery, loss to measure body composition, and percentage body fat < 4% were excluded.
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 |
|---|---|---|
| Hemodialysis eating index (HDEI) base education interventionThe investigators have developed the educational materials for patients, in order to improve the dialysis outcomes. The interventions will be delivered to patients and nurses in hospital based hemodialysis centers. | Behavioural | CN group, CNP group, CP group |
Primary outcome
Health Literacy
Time frame: baseline
Health literacy will be also measured by Chew's 3 brief health literacy screening questions (BHLS), each with 5 possible response options: (1) "How often do you have problems learning about your medical condition because of difficulty understanding written information?" (always, often, sometimes, occasionally, or never); (2) "How often do you have someone help you read hospital materials?" (always, often, sometimes, occasionally, or never); and (3) "How confident are you filling out medical forms by yourself?" (extremely, quite a bit, somewhat, a little bit, or not at all).
1 secondary outcome
Dietary knowledge
Time frame: 2 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 20 Jul 2022.
- Background: PubMed 15343421Chew LD, Bradley KA, Boyko EJ. Brief questions to identify patients with inadequate health literacy. Fam Med. 2004 Sep;36(8):588-94.
- Background: PubMed 26251719Cavanaugh KL, Osborn CY, Tentori F, Rothman RL, Ikizler TA, Wallston KA. Performance of a brief survey to assess health literacy in patients receiving hemodialysis. Clin Kidney J. 2015 Aug;8(4):462-8. doi: 10.1093/ckj/sfv037. Epub 2015 Jun 10.
- Background: PubMed 16881950Wallace LS, Rogers ES, Roskos SE, Holiday DB, Weiss BD. Brief report: screening items to identify patients with limited health literacy skills. J Gen Intern Med. 2006 Aug;21(8):874-7. doi: 10.1111/j.1525-1497.2006.00532.x.
- Background: PubMed 29064180Duff EA, Chawke FM. A service review to assess if innovative intensive phosphate dietary education can help reduce phosphate levels to the recommended range in a hemodialysis population. Hemodial Int. 2017 Oct;21 Suppl 2:S22-S26. doi: 10.1111/hdi.12593.
- Background: PubMed 20830945Kim Y, Evangelista LS, Phillips LR, Pavlish C, Kopple JD. The End-Stage Renal Disease Adherence Questionnaire (ESRD-AQ): testing the psychometric properties in patients receiving in-center hemodialysis. Nephrol Nurs J. 2010 Jul-Aug;37(4):377-93.
- Background: PubMed 7841967Hays RD, Kallich JD, Mapes DL, Coons SJ, Carter WB. Development of the kidney disease quality of life (KDQOL) instrument. Qual Life Res. 1994 Oct;3(5):329-38. doi: 10.1007/BF00451725.
- Background: PubMed 26215978Wan EY, Chen JY, Choi EP, Wong CK, Chan AK, Chan KH, Lam CL. Patterns of health-related quality of life and associated factors in Chinese patients undergoing haemodialysis. Health Qual Life Outcomes. 2015 Jul 29;13:108. doi: 10.1186/s12955-015-0308-3.
- Background: PubMed 21172008Joshi VD, Mooppil N, Lim JF. Validation of the kidney disease quality of life-short form: a cross-sectional study of a dialysis-targeted health measure in Singapore. BMC Nephrol. 2010 Dec 20;11:36. doi: 10.1186/1471-2369-11-36.
- Background: PubMed 16807105Macfarlane DJ, Lee CC, Ho EY, Chan KL, Chan DT. Reliability and validity of the Chinese version of IPAQ (short, last 7 days). J Sci Med Sport. 2007 Feb;10(1):45-51. doi: 10.1016/j.jsams.2006.05.003. Epub 2006 Jun 30.
- Background: PubMed 19061172Liou YM, Jwo CJ, Yao KG, Chiang LC, Huang LH. Selection of appropriate Chinese terms to represent intensity and types of physical activity terms for use in the Taiwan version of IPAQ. J Nurs Res. 2008 Dec;16(4):252-63. doi: 10.1097/01.jnr.0000387313.20386.0a.
- Individual participant dataSharing planned: No. We need more time to clear the data.
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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.
Shwu-Huey Yang, Ph.D principal investigator
Taipei Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hemodialysis eating index (HDEI) base education intervention in people with Hemodialysis Complication, run by Taipei Medical University at 1 site in Taiwan.
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 1 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 20 Jul 2022. 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 Taiwan. 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?
Health Literacy (time frame: baseline). 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 NCT05466773, which also lists 10 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 20 Jul 2022.