Renal FailureDOPRONCT05441020
Development, Feasibility Testing and Validation of a Survey Set to Measure Patient-Reported Outcomes Among Hemodialysis Patients in Turkey
An observational study of Renal Failure and End Stage Renal Disease, run by Fresenius Medical Care Deutschland GmbH at 7 sites in Turkey (Türkiye).
Trial summary
Development, feasibility testing and validation of a Survey Set to Measure Patient-Reported Outcomes among Hemodialysis Patients in Turkey: Creating and testing an electronic patient questionnaire that is suitable to measure health-related quality of life in Turkish dialysis patients in clinical as well as in home… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Renal Failure, End Stage Renal Disease
- What is being tested?
- Administration of patient questionnaire
- Type of treatment
- Pill or oral medicine
- How many people
- 173 participants
- Where
- 7 sitesTurkey (Türkiye)
- Study dates
- 18 Nov 2022to 20 Mar 2023
- Phase
- Observational
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Turkish dialysis patients (in center or home dialysis)
Who may be able to join
- Informed consent signed and dated by study patient and investigator/authorized physician
- Age of 18 -80 years
- Ability to understand the nature and requirements of the study
- Literacy in Turkish including the ability to read with regards to visual acuity and the ability to understand what is read
- General ability to use a tablet (the study nurse will instruct the patient how to use the study-tablet during the conduct of the study)
- To be on stable maintenance hemodialysis (HD) for over 3 months (prevalent patients)
Who cannot join
- Any conditions which could interfere with the patient's ability to comply with the study
- Previous participation in the same study
- Participation in an interventional clinical study during the preceding 30 days
- Serious life-limiting co-morbid situations, namely active malignancy, active infection, end-stage cardiac, pulmonary, or hepatic disease, which causes life-expectancy less than a year,
- Acute cardiovascular events including myocardial infarction, stroke and unstable angina pectoris requiring hospitalization within the last 6 months,
- To have cognitive or mental co-morbidities which prevent reliable answering of questions
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Turkey (Türkiye)7 sites
Fresenius Nefroloji Hizmetleri A.Ş.-Bornova Branch
Izmir, 35040
Fresenius Nefroloji Hizmetleri A.Ş.-Buca Branch
Izmir, 35340
Fresenius Nefroloji Hizmetleri A.Ş.-İzmir Üçkuyular Branch
Izmir, 35340
Fresenius Nefroloji Hizmetleri A.Ş.-İzmir Hatay Branch
Izmir, 35360
İzmir Renal Özel Sağlık Tesisleri ve Malzemeleri Sanayi Tic. A.Ş- Yeşilyurt Branch
Izmir, 35370
Gaziemir Özel Sağlık Hizmetleri Tesisleri Malzemeleri Sanayi ve Tic. A.Ş. - Gaziemir Branch
Izmir, 35410
Fresenius Nefroloji Hizmetleri A.Ş.-Karşıyaka Branch
Izmir, 35510
About this study
Development, feasibility testing and validation of a Survey Set to Measure Patient-Reported Outcomes among Hemodialysis Patients in Turkey: Creating and testing an electronic patient questionnaire that is suitable to measure health-related quality of life in Turkish dialysis patients in clinical as well as in home care settings.
Read the detailed description
Individuals with chronic kidney disease represent a growing population in adult and pediatric practices. This has resulted in a drive to optimize patient care and outcomes. Historically, healthcare outcomes focused on morbidity, mortality or complication rates, but failed to provide meaningful data on the value of medicine to patients and the quality of life gained or lost. Several studies have revealed that treatments aimed at minimizing morbidity and mortality in end-stage renal disease (ESRD) have very often been ineffective. Therefore, attention to HRQOL among ESRD patients is crucial.
The aim of this pilot study is creating and testing an electronic patient questionnaire that is suitable to measure health-related quality of life in Turkish dialysis patients. This questionnaire consists of the PROMIS Cognitive Function and Abilities Subset, the PROMIS-29, a new post-dialysis recovery time module, the MOS-Social Support Scale (MOS-SSS), Subscales of the KDQOL SF 1.3 (sexual function \& cognitive function), the General Self-Efficacy Scale and the Health Services Utilization And Productivity Loss Survey which are to be delivered together on a tablet computer.
- Conditions
- Renal Failure, End Stage Renal Disease
- Being tested
- Administration of patient questionnaire
- Keywords
- Hemodialysis, Psychometric tests, Patient questionnaire
- Medical subject headings
- Renal Insufficiency, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of patient questionnaireOther
Patients undergoing maintenance hemodialysis complete electronic questionnaires on a tablet computer during this study to assess patient reported outcomes.
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of Patient Reported Outcome Measures Information System-29 (PROMIS-29)
Measured: 2 weeks between test and retest
Translating and testing PROMIS Cognitive Function and Abilities Subscale (PROMIS-CFS)
Measured: 2 weeks between test and retest
Translating and testing feasibility of a new post-dialysis recovery time module adapted from PROMIS scale on fatigue
Measured: Single Administration in cross-sectional design
Testing feasibility and usefulness of measuring Social Support, potential reduction of items and internal consistency of the MOS-Social Support Scale (MOS-SSS)
Measured: Single Administration in cross-sectional design
Assessing feasibility and usefulness of measuring General Self-Efficacy Scale (GSE)
Measured: Single Administration in cross-sectional design
Testing feasibility of the Telephone Cognitive Screen (T-Cog-S)
Measured: Single Administration in cross-sectional design
Testing feasibility of the kidney disease targeted subscales (sexual function & cognitive function) of the Kidney Disease Quality of Life Short Form Version 1.3 (KDQOL SF 1.3)
Measured: Single Administration in cross-sectional design
Testing feasibility of Health Services Utilization and Productivity Loss Survey
Measured: Single Administration in cross-sectional design
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2022
- Study start18 Nov 2022
- Primary completion2 Feb 2023
- Study completion20 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal FailureStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fresenius Medical Care Deutschland GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- acromion GmbH, Vector Psychometric Group, LLC
- Responsible party
- Sponsor
- Investigators
- Hayriye Elbi, Prof Dr, Principal investigator, Ege University Medical Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05441020
- Sponsor's protocol ID
- HD-HOME-01-TR
- Acronym
- DOPRO
- Status last verified
- Jul 2023
- First submitted
- 18 May 2022
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development, Feasibility Testing and Validation of a Survey Set to Measure Patient-Reported Outcomes Among Hemodialysis Patients in Turkey
- ClinicalTrials.gov ID
- NCT05441020
- Acronym / sponsor ID
- DOPRO / HD-HOME-01-TR
- Conditions
- Renal Failure, End Stage Renal Disease
- Keywords
- Hemodialysis, Psychometric tests, Patient questionnaire
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- Fresenius Medical Care Deutschland GmbHIndustry (pharma, biotech, devices)
- Collaborators
- acromion GmbH, Vector Psychometric Group, LLC
- Study start
- 18 Nov 2022 (actual)
- Primary completion
- 2 Feb 2023 (actual)
- Study completion
- 20 Mar 2023 (actual)
- First posted
- 1 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.
Development, feasibility testing and validation of a Survey Set to Measure Patient-Reported Outcomes among Hemodialysis Patients in Turkey: Creating and testing an electronic patient questionnaire that is suitable to measure health-related quality of life in Turkish dialysis patients in clinical as well as in home care settings.
Detailed description
Individuals with chronic kidney disease represent a growing population in adult and pediatric practices. This has resulted in a drive to optimize patient care and outcomes. Historically, healthcare outcomes focused on morbidity, mortality or complication rates, but failed to provide meaningful data on the value of medicine to patients and the quality of life gained or lost. Several studies have revealed that treatments aimed at minimizing morbidity and mortality in end-stage renal disease (ESRD) have very often been ineffective. Therefore, attention to HRQOL among ESRD patients is crucial.
The aim of this pilot study is creating and testing an electronic patient questionnaire that is suitable to measure health-related quality of life in Turkish dialysis patients. This questionnaire consists of the PROMIS Cognitive Function and Abilities Subset, the PROMIS-29, a new post-dialysis recovery time module, the MOS-Social Support Scale (MOS-SSS), Subscales of the KDQOL SF 1.3 (sexual function \& cognitive function), the General Self-Efficacy Scale and the Health Services Utilization And Productivity Loss Survey which are to be delivered together on a tablet computer.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Turkish dialysis patients (in center or home dialysis)
Key inclusion criteria (6 listed)
- Informed consent signed and dated by study patient and investigator/authorized physician
- Age of 18 -80 years
- Ability to understand the nature and requirements of the study
- Literacy in Turkish including the ability to read with regards to visual acuity and the ability to understand what is read
- General ability to use a tablet (the study nurse will instruct the patient how to use the study-tablet during the conduct of the study)
Key exclusion criteria (6 listed)
- Any conditions which could interfere with the patient's ability to comply with the study
- Previous participation in the same study
- Participation in an interventional clinical study during the preceding 30 days
- Serious life-limiting co-morbid situations, namely active malignancy, active infection, end-stage cardiac, pulmonary, or hepatic disease, which causes life-expectancy less than a year,
- Acute cardiovascular events including myocardial infarction, stroke and unstable angina pectoris requiring hospitalization within the last 6 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 |
|---|---|---|
| Administration of patient questionnairePatients undergoing maintenance hemodialysis complete electronic questionnaires on a tablet computer during this study to assess patient reported outcomes. | Other | – |
Primary outcome
Validation of Patient Reported Outcome Measures Information System-29 (PROMIS-29)
Time frame: 2 weeks between test and retest
Translating and testing PROMIS Cognitive Function and Abilities Subscale (PROMIS-CFS)
Time frame: 2 weeks between test and retest
Translating and testing feasibility of a new post-dialysis recovery time module adapted from PROMIS scale on fatigue
Time frame: Single Administration in cross-sectional design
Testing feasibility and usefulness of measuring Social Support, potential reduction of items and internal consistency of the MOS-Social Support Scale (MOS-SSS)
Time frame: Single Administration in cross-sectional design
Assessing feasibility and usefulness of measuring General Self-Efficacy Scale (GSE)
Time frame: Single Administration in cross-sectional design
Testing feasibility of the Telephone Cognitive Screen (T-Cog-S)
Time frame: Single Administration in cross-sectional design
Testing feasibility of the kidney disease targeted subscales (sexual function & cognitive function) of the Kidney Disease Quality of Life Short Form Version 1.3 (KDQOL SF 1.3)
Time frame: Single Administration in cross-sectional design
Testing feasibility of Health Services Utilization and Productivity Loss Survey
Time frame: Single Administration in cross-sectional design
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 1 Aug 2023.
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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.
Hayriye Elbi, Prof Dr principal investigator
Ege University Medical Faculty
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Failure and End Stage Renal Disease, run by Fresenius Medical Care Deutschland GmbH at 7 sites 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 6 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 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
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?
Validation of Patient Reported Outcome Measures Information System-29 (PROMIS-29) (time frame: 2 weeks between test and retest). The study lists 8 primary outcomes in all. 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 1 Aug 2023.