Renal DiseaseNCT04174638
The Effect of Motivational Interviewing and Education Based on Watson's Theory of Human Caring in Hemodialysis
A study testing Motivational Interviewing and Education Based on Watson's Theory of Human Caring in people with Renal Disease and Adherence, Treatment, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
Motivational interviewing and education based on Watson's Theory of Human Caring have an effect on increasing adherence to fluid intake in individuals receiving hemodialysis treatment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Renal Disease, Adherence, Treatment, Quality of Life
- What is being tested?
- Motivational Interviewing and Education Based on Watson's Theory of Human Caring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2019to 17 Jun 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patients who were receive hemodialysis at Hemodialysis Unit of University Hospital in Antalya, Turkey
- Patients who had 1 and above from Diet And Fluid Non-Adherence Questionnaire total score
- Patients who had 0 or 1 score from 1.2. and 6. questions or 3., 4. and 5. questions in the Modified Morisky Scale.
- Patients who receiving Hemodialysis treatment for at least 3 months
- Patients who were over 18 years of age,
- Patients who had orientation of individual, place and time
Show all 9Show fewer
- Patients who were literate
- Patients who no barriers to written or verbal communication
- Patients who agree to participate in the study
Who cannot join
- Patients who had psychiatric disease
- Patients who had diagnosis of malignancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Motivational Interviewing and Education Based on Watson's Theory of Human Caring in Individuals Receiving Hemodialysis: Randomized Controlled Trial
- Motivational interviewing and education based on Watson's Theory of Human Caring have an effect on increasing adherence to fluid intake in individuals receiving hemodialysis treatment.
- Motivational interviewing and education based on Watson's Theory of Human Caring have an effect on increasing adherence to diet in individuals receiving hemodialysis treatment.
- Motivational interviewing and education based on Watson's Theory of Human Caring have an effect on increasing adherence to drug management in individuals receiving hemodialysis treatment.
- Intervention group who receiving Motivational interviewing and education based on Watson's Theory of Human Caring would satisfied with introduced intervention.
- Motivational interviewing and education based on Watson's Theory of Human Caring have an effect on increasing quality of life in individuals receiving hemodialysis treatment.
Read the detailed description
The intervention group received 15 minute motivational interviewing based on Watson's Theory of Human Caring once a month for 12 weeks and one session 30 minutes education with educational booklet based on Watson's Theory of Human Caring. The control group received usual care. Adherence to fluid intake, diet and drug management, physical parameters and quality of life was measured at baseline and 12th week. The patient satisfaction was measured in the intervention group at 12th week.
- Being tested
- Motivational Interviewing and Education Based on Watson's Theory of Human Caring
- Keywords
- Compliance, Motivational Interviewing, Models, Nursing, Nursing, Patient Satisfaction, Quality of Life, Randomized Controlled Trial, Renal Dialysis
- Medical subject headings
- Kidney Diseases, Treatment Adherence and Compliance, Patient Satisfaction, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational Interviewing and Education Based on Watson's Theory of Human CaringOther
The intervention group received 15 minute motivational interviewing based on Watson's Theory of Human Caring once a month for 12 weeks and one session 30 minutes education with educational booklet based on Watson's Theory of Human Caring. The intervention performed before the hemodialysis session in a separate room in the hemodialysis unit.
| Study group | Role | What they receive |
|---|---|---|
| "Intervention Group" | Experimental | The intervention group received 15 minute motivational interviewing based on Watson's Theory of Human Caring once a month for 12 weeks and one session 30 minutes education with educational booklet based on Watson's Theory of Human Caring. Receives: Other: Motivational Interviewing and Education Based on Watson's Theory of Human Caring |
| "Control Group" | No intervention | The control group received routine hemodialysis treatment and nursing care in the hemodialysis unit. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Adherence to Fluid Intake on the Fluid Control in Hemodialysis Patients Scale at Week 12
This scale measure adherence to fluid intake.The scale had 24 items and 3 point likert scale. It was included three sub-dimensions: knowledge, behaviors, and attitudes. The knowledge sub-dimension included 7 items and it's score ranged from 7-21. A high score indicates that individuals have higher levels of knowledge about fluid intake. The behavior sub-dimension included 11 items and it's score ranged from 11-33. A high score indicates that individuals' behavior is positive in adherence to fluid intake. The attitudes sub-dimension included 6 items and it's score ranged from 6-18. A high score indicates that individuals' attitudes is positive in adherence to fluid intake. The Fluid Control in Hemodialysis Patients Scale is evaluated on the total score. The lowest and highest score is between 24 and 72. High score indicates that adherence to fluid intake is high.The scale was developed in Turkey. The change between week 12 score and baseline score was reported.
Measured: baseline and 12 week
Change From Baseline in Adherence to Diet on the Scale for Dietary Behaviors in Hemodialysis Patients at Week 12
Scale for Dietary Behaviors in Hemodialysis Patients: This scale evaluate adherence to diet management in hemodialysis patients. The scale had 13 items and 5 point likert scale. The score ranged from 13-65. High score indicates that adherence to diet management is high. The scale was developed in Turkey.The change between week 12 score and baseline score was reported.
Measured: Baseline and 12 week
Change From Baseline in Adherence to Drug Management on the Modified Morisky Scale at Week 12
Modified Morisky Scale: This scale evaluate adherence to drug management. It is consist of six items and two sub-dimensions:knowledge and motivation. The lowest and highest score is between 0-3 for each sub-dimension. A score higher than zero each sub-dimension indicates high knowledge and motivation in the adherence to drug management. The change between week 12 score and baseline score was reported
Measured: Baseline and 12 week
Change From Baseline in Adherence to Participation in Dialysis Sessions on the Hemodialysis Session Participation Form at Week 4,8,12
Hemodialysis Session Participation Form: This form was used to evaluated the adherence to participation in dialysis sessions at monthly and it was prepared by the researcher. It consisted of yes and no items. If the participant attended all monthly sessions, yes item was marked, if not, no was marked, and the number of sessions did not attend was noted. It was calculated that the mean of the monthly hemodialysis sessions they did not attend.
The change between week 4, 8, 12 score and baseline score was reported.
Measured: baseline and 4, 8, 12 week
The Mean of Satisfaction of the Intervention Group From the Introduced Intervention Based on Theory Using Watson Caritas Patient Score at Week 12
Watson Caritas Patient Score: This questionnaire evaluate the satisfaction with nursing care based on Watson's Theory of Human Caring. It is a likert-type form consist of five items. The score of each item ranged from 1-7. As the mean score from each item approaches 7, it shows that individuals are satisfied with care. This questionnaire will perform only to the intervention group. The mean score of the each item of the questionnaire was reported. The data were not collected for this Outcome Measure from participants in the "Control Group" Arm/Group.
Measured: 12 week
The Mean of Satisfaction From the Motivational Interviewing Evaluated With Motivational Interview Evaluation Form at Week 12
Motivational Interview Evaluation Form: This form was used to evaluated the satisfaction with motivational interviewing and it was prepared by the researcher. This form consists of a item that includes evaluating the motivational interviewing satisfaction with likert scale and two items that include evaluating the inadequacies of the interviewing with open-ended question. The total mean score ranged from 1-5. As the mean score from first item approaches 5, it shows that individuals are satisfied with motivational interviewing.This form will perform only to the intervention group. The mean of the Motivational Interview Evaluation Form was reported.The data were not collected for this Outcome Measure from participants in the "Control Group" Arm/Group.
Measured: 12 week
Change From Baseline in Quality of Life on the Kidney Disease Quality of Life Instrument 36 Scale at Week 12
Kidney Disease Quality of Life Instrument 36 ıtem:This instrument evaluate quality of life of individuals with chronic kidney disease. The KDQOL-36 consists of 36 items and five sub-dimensions: physical and mental functions, kidney disease burden, symptoms and problems, effects of kidney disease on daily life. The scoring of the each sub-scale ranges from 0 to 100. A higher score in each sub-dimension is an indicator of better health and quality of life. The change between week 12 score and baseline score was reported.
Measured: baseline and 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2019
- Study start1 Apr 2019
- Primary completion1 Apr 2020
- Study completion17 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Renal DiseaseStudies of the same condition, open and under way.
- More trials run by Akdeniz 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a parallel group randomized controlled study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Şefika Tuğba YANGÖZ, Akdeniz University
- Investigators
- Zeynep ÖZER, PhD, RN, Study director, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04174638
- Sponsor's protocol ID
- Akdeniz University
- Status last verified
- Feb 2021
- First submitted
- 21 Jul 2019
- Last updated
- 23 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD will share.
Publications
Tarverdizade Asl P, Lakdizaji S, Ghahramanian A, Seyedrasooli A, Ghavipanjeh Rezaiy S. Effectiveness of Text Messaging and Face to Face Training on Improving Knowledge and Quality of Life of Patients undergoing Hemodialysis: a Randomized Clinical Trial. J Caring Sci. 2018 Jun 1;7(2):95-100. doi: 10.15171/jcs.2018.015. eCollection 2018 Jun.
PubMed 29977880Kim K, Kang GW, Woo J. The Quality of Life of Hemodialysis Patients Is Affected Not Only by Medical but also Psychosocial Factors: a Canonical Correlation Study. J Korean Med Sci. 2018 Apr 2;33(14):e111. doi: 10.3346/jkms.2018.33.e111.
PubMed 29607636Marcus C. Strategies for improving the quality of verbal patient and family education: a review of the literature and creation of the EDUCATE model. Health Psychol Behav Med. 2014 Jan 1;2(1):482-495. doi: 10.1080/21642850.2014.900450. Epub 2014 Apr 28.
PubMed 25750796Nabolsi MM, Wardam L, Al-Halabi JO. Quality of life, depression, adherence to treatment and illness perception of patients on haemodialysis. Int J Nurs Pract. 2015 Feb;21(1):1-10. doi: 10.1111/ijn.12205. Epub 2013 Oct 11.
PubMed 24124912Beto JA, Schury KA, Bansal VK. Strategies to promote adherence to nutritional advice in patients with chronic kidney disease: a narrative review and commentary. Int J Nephrol Renovasc Dis. 2016 Feb 2;9:21-33. doi: 10.2147/IJNRD.S76831. eCollection 2016.
PubMed 26893578Efe D, Kocaoz S. Adherence to diet and fluid restriction of individuals on hemodialysis treatment and affecting factors in Turkey. Jpn J Nurs Sci. 2015 Apr;12(2):113-23. doi: 10.1111/jjns.12055. Epub 2014 Aug 13.
PubMed 25123654
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Motivational Interviewing and Education Based on Watson's Theory of Human Caring in Individuals Receiving Hemodialysis: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04174638
- Acronym / sponsor ID
- Akdeniz University
- Keywords
- Compliance, Motivational Interviewing, Models, Nursing, Nursing, Patient Satisfaction, Quality of Life, Randomized Controlled Trial, Renal Dialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 17 Jun 2020 (actual)
- First posted
- 22 Nov 2019 (actual)
- Results
- Posted 23 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Motivational interviewing and education based on Watson's Theory of Human Caring have an effect on increasing adherence to fluid intake in individuals receiving hemodialysis treatment.
- Motivational interviewing and education based on Watson's Theory of Human Caring have an effect on increasing adherence to diet in individuals receiving hemodialysis treatment.
- Motivational interviewing and education based on Watson's Theory of Human Caring have an effect on increasing adherence to drug management in individuals receiving hemodialysis treatment.
- Intervention group who receiving Motivational interviewing and education based on Watson's Theory of Human Caring would satisfied with introduced intervention.
- Motivational interviewing and education based on Watson's Theory of Human Caring have an effect on increasing quality of life in individuals receiving hemodialysis treatment.
Detailed description
The intervention group received 15 minute motivational interviewing based on Watson's Theory of Human Caring once a month for 12 weeks and one session 30 minutes education with educational booklet based on Watson's Theory of Human Caring. The control group received usual care. Adherence to fluid intake, diet and drug management, physical parameters and quality of life was measured at baseline and 12th week. The patient satisfaction was measured in the intervention group at 12th week.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study is a parallel group randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| "Intervention Group" | Experimental | Other: Motivational Interviewing and Education Based on Watson's Theory of Human CaringThe intervention group received 15 minute motivational interviewing based on Watson's Theory of Human Caring once a month for 12 weeks and one session 30 minutes education with educational booklet based on Watson's Theory of Human Caring. |
| "Control Group" | No intervention | –The control group received routine hemodialysis treatment and nursing care in the hemodialysis unit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients who were receive hemodialysis at Hemodialysis Unit of University Hospital in Antalya, Turkey
- Patients who had 1 and above from Diet And Fluid Non-Adherence Questionnaire total score
- Patients who had 0 or 1 score from 1.2. and 6. questions or 3., 4. and 5. questions in the Modified Morisky Scale.
- Patients who receiving Hemodialysis treatment for at least 3 months
- Patients who were over 18 years of age,
Key exclusion criteria (2 listed)
- Patients who had psychiatric disease
- Patients who had diagnosis of malignancy
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 |
|---|---|---|
| Motivational Interviewing and Education Based on Watson's Theory of Human CaringThe intervention group received 15 minute motivational interviewing based on Watson's Theory of Human Caring once a month for 12 weeks and one session 30 minutes education with educational booklet based on Watson's Theory of Human Caring. The intervention performed before the hemodialysis session in a separate room in the hemodialysis unit. | Other | "Intervention Group" |
Primary outcome
Change From Baseline in Adherence to Fluid Intake on the Fluid Control in Hemodialysis Patients Scale at Week 12
Time frame: baseline and 12 week
This scale measure adherence to fluid intake.The scale had 24 items and 3 point likert scale. It was included three sub-dimensions: knowledge, behaviors, and attitudes. The knowledge sub-dimension included 7 items and it's score ranged from 7-21. A high score indicates that individuals have higher levels of knowledge about fluid intake. The behavior sub-dimension included 11 items and it's score ranged from 11-33. A high score indicates that individuals' behavior is positive in adherence to fluid intake. The attitudes sub-dimension included 6 items and it's score ranged from 6-18. A high score indicates that individuals' attitudes is positive in adherence to fluid intake. The Fluid Control in Hemodialysis Patients Scale is evaluated on the total score. The lowest and highest score is between 24 and 72. High score indicates that adherence to fluid intake is high.The scale was developed in Turkey. The change between week 12 score and baseline score was reported.
Change From Baseline in Adherence to Diet on the Scale for Dietary Behaviors in Hemodialysis Patients at Week 12
Time frame: Baseline and 12 week
Scale for Dietary Behaviors in Hemodialysis Patients: This scale evaluate adherence to diet management in hemodialysis patients. The scale had 13 items and 5 point likert scale. The score ranged from 13-65. High score indicates that adherence to diet management is high. The scale was developed in Turkey.The change between week 12 score and baseline score was reported.
Change From Baseline in Adherence to Drug Management on the Modified Morisky Scale at Week 12
Time frame: Baseline and 12 week
Modified Morisky Scale: This scale evaluate adherence to drug management. It is consist of six items and two sub-dimensions:knowledge and motivation. The lowest and highest score is between 0-3 for each sub-dimension. A score higher than zero each sub-dimension indicates high knowledge and motivation in the adherence to drug management. The change between week 12 score and baseline score was reported
Change From Baseline in Adherence to Participation in Dialysis Sessions on the Hemodialysis Session Participation Form at Week 4,8,12
Time frame: baseline and 4, 8, 12 week
Hemodialysis Session Participation Form: This form was used to evaluated the adherence to participation in dialysis sessions at monthly and it was prepared by the researcher. It consisted of yes and no items. If the participant attended all monthly sessions, yes item was marked, if not, no was marked, and the number of sessions did not attend was noted. It was calculated that the mean of the monthly hemodialysis sessions they did not attend. The change between week 4, 8, 12 score and baseline score was reported.
The Mean of Satisfaction of the Intervention Group From the Introduced Intervention Based on Theory Using Watson Caritas Patient Score at Week 12
Time frame: 12 week
Watson Caritas Patient Score: This questionnaire evaluate the satisfaction with nursing care based on Watson's Theory of Human Caring. It is a likert-type form consist of five items. The score of each item ranged from 1-7. As the mean score from each item approaches 7, it shows that individuals are satisfied with care. This questionnaire will perform only to the intervention group. The mean score of the each item of the questionnaire was reported. The data were not collected for this Outcome Measure from participants in the "Control Group" Arm/Group.
The Mean of Satisfaction From the Motivational Interviewing Evaluated With Motivational Interview Evaluation Form at Week 12
Time frame: 12 week
Motivational Interview Evaluation Form: This form was used to evaluated the satisfaction with motivational interviewing and it was prepared by the researcher. This form consists of a item that includes evaluating the motivational interviewing satisfaction with likert scale and two items that include evaluating the inadequacies of the interviewing with open-ended question. The total mean score ranged from 1-5. As the mean score from first item approaches 5, it shows that individuals are satisfied with motivational interviewing.This form will perform only to the intervention group. The mean of the Motivational Interview Evaluation Form was reported.The data were not collected for this Outcome Measure from participants in the "Control Group" Arm/Group.
Change From Baseline in Quality of Life on the Kidney Disease Quality of Life Instrument 36 Scale at Week 12
Time frame: baseline and 12 week
Kidney Disease Quality of Life Instrument 36 ıtem:This instrument evaluate quality of life of individuals with chronic kidney disease. The KDQOL-36 consists of 36 items and five sub-dimensions: physical and mental functions, kidney disease burden, symptoms and problems, effects of kidney disease on daily life. The scoring of the each sub-scale ranges from 0 to 100. A higher score in each sub-dimension is an indicator of better health and quality of life. The change between week 12 score and baseline score was reported.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29977880Tarverdizade Asl P, Lakdizaji S, Ghahramanian A, Seyedrasooli A, Ghavipanjeh Rezaiy S. Effectiveness of Text Messaging and Face to Face Training on Improving Knowledge and Quality of Life of Patients undergoing Hemodialysis: a Randomized Clinical Trial. J Caring Sci. 2018 Jun 1;7(2):95-100. doi: 10.15171/jcs.2018.015. eCollection 2018 Jun.
- Background: PubMed 29607636Kim K, Kang GW, Woo J. The Quality of Life of Hemodialysis Patients Is Affected Not Only by Medical but also Psychosocial Factors: a Canonical Correlation Study. J Korean Med Sci. 2018 Apr 2;33(14):e111. doi: 10.3346/jkms.2018.33.e111.
- Background: PubMed 25750796Marcus C. Strategies for improving the quality of verbal patient and family education: a review of the literature and creation of the EDUCATE model. Health Psychol Behav Med. 2014 Jan 1;2(1):482-495. doi: 10.1080/21642850.2014.900450. Epub 2014 Apr 28.
- Background: PubMed 24124912Nabolsi MM, Wardam L, Al-Halabi JO. Quality of life, depression, adherence to treatment and illness perception of patients on haemodialysis. Int J Nurs Pract. 2015 Feb;21(1):1-10. doi: 10.1111/ijn.12205. Epub 2013 Oct 11.
- Background: PubMed 26893578Beto JA, Schury KA, Bansal VK. Strategies to promote adherence to nutritional advice in patients with chronic kidney disease: a narrative review and commentary. Int J Nephrol Renovasc Dis. 2016 Feb 2;9:21-33. doi: 10.2147/IJNRD.S76831. eCollection 2016.
- Background: PubMed 25123654Efe D, Kocaoz S. Adherence to diet and fluid restriction of individuals on hemodialysis treatment and affecting factors in Turkey. Jpn J Nurs Sci. 2015 Apr;12(2):113-23. doi: 10.1111/jjns.12055. Epub 2014 Aug 13.
- he effect of nursing counseling on improving knowledge, adherence to treatment and quality of life of patients undergoing hemodialysis.Link provided by the sponsor.
- Quality of life in hemodialysis patients and the relationship with mortality, hospitalizations and poor treatment adherenceLink provided by the sponsor.
- The Effect of Nursing Counseling on Improving Knowledge, Adherence to Treatment and Quality of Life of Patients Undergoing HemodialysisLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All collected IPD will share.
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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.
Zeynep ÖZER, PhD, RN study director
Akdeniz 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 Motivational Interviewing and Education Based on Watson's Theory of Human Caring in people with Renal Disease and Adherence, Treatment, run by Akdeniz University at 1 site in Turkey (Türkiye).
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 9 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: finished, as of the sponsor's last update on 23 Feb 2021. 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 Turkey (Türkiye). 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?
Yes. Results are posted in the registry (first posted 23 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline in Adherence to Fluid Intake on the Fluid Control in Hemodialysis Patients Scale at Week 12 (time frame: baseline and 12 week). The study lists 7 primary outcomes in all. 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 NCT04174638, which also lists 6 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 23 Feb 2021.