Quality of LifeNCT04047069
The Effect of Occupational Therapy Intervention in Hemodialysis Patients
A study testing Awareness Training and Person-Centered Occupational Therapy Intervention and Awareness Training in people with Quality of Life, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the effect of person-centre occupational therapy intervention on activity performance and quality of life in hemodialysis patients. The results of the study will guide the intervention programs for prevention, coping and improving the quality of life of HD patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Quality of Life
- What is being tested?
- Awareness Training and Person-Centered Occupational Therapy Intervention and Awareness Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2019to 30 Oct 2019
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosed as chronic renal failure.
- between 18-65 years
- undergoing HD treatment for at least 1 year
Who cannot join
- Beck Depression Scale score of 17 or higher
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Person-Centered Occupational Therapy Intervention on Occupational Performance and Quality of Life in Hemodialysis Patients
The aim of this study is to investigate the effect of person-centre occupational therapy intervention on activity performance and quality of life in hemodialysis patients. The results of the study will guide the intervention programs for prevention, coping and improving the quality of life of HD patients.
- Conditions
- Quality of Life
- Being tested
- Awareness Training and Person-Centered Occupational Therapy Intervention, Awareness Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Awareness Training and Person-Centered Occupational Therapy InterventionBehavioural
Exp. identifying the activities the person wants to do, suggestions to facilitate the activity, arranging the activity according to the needs of the person, arranging the environment so that the environment can be a facilitating factor in the activities the person wants to do.
Awareness TrainingBehavioural
Exp.
- General information about HD
- Approaches to Coping with HD Symptoms
- Self care skills (eg hygiene)
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | Awareness Training Receives: Behavioral: Awareness Training |
| Intervention group | Experimental | * Awareness Training
* Person-Centered Occupational Therapy Intervention Receives: Behavioral: Awareness Training and Person-Centered Occupational Therapy Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life (with a quality of life scale specific to renal patients).
The KidneyDisease Quality of Life (KDQOL-36) consists of the SF-12, which measures physical and mental functioning, Burden of Kidney Disease subscale, Symptoms and Problems subscale, and Effects of Kidney Disease on Daily Life subscale. The scores of theKDQOL-36 questionnaire are transformed into 0 to 100, with higherscores indicating better quality of life.combines the generic SF-36 Health Survey instrument and disease-specific components for assessing the health-related quality of life of
Measured: 1st day of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2019
- Study start1 Jul 2019
- Primary completion12 Aug 2019 (estimated)
- Study completion30 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by Hacettepe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özgü İNAL, Hacettepe University
- Investigators
- Özgü İnal, Principal investigator, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04047069
- Sponsor's protocol ID
- 2019/257
- Status last verified
- Aug 2019
- First submitted
- 1 Aug 2019
- Last updated
- 6 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Person-Centered Occupational Therapy Intervention on Occupational Performance and Quality of Life in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT04047069
- Acronym / sponsor ID
- 2019/257
- Conditions
- Quality of Life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 12 Aug 2019 (estimated)
- Study completion
- 30 Oct 2019 (estimated)
- First posted
- 6 Aug 2019 (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 aim of this study is to investigate the effect of person-centre occupational therapy intervention on activity performance and quality of life in hemodialysis patients. The results of the study will guide the intervention programs for prevention, coping and improving the quality of life of HD patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Behavioral: Awareness TrainingAwareness Training |
| Intervention group | Experimental | Behavioral: Awareness Training and Person-Centered Occupational Therapy Intervention* Awareness Training * Person-Centered Occupational Therapy Intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diagnosed as chronic renal failure.
- between 18-65 years
- undergoing HD treatment for at least 1 year
Key exclusion criteria (1 listed)
- Beck Depression Scale score of 17 or higher
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 |
|---|---|---|
| Awareness Training and Person-Centered Occupational Therapy InterventionExp. identifying the activities the person wants to do, suggestions to facilitate the activity, arranging the activity according to the needs of the person, arranging the environment so that the environment can be a facilitating factor in the activities the person wants to do. | Behavioural | Intervention group |
| Awareness TrainingExp. * General information about HD * Approaches to Coping with HD Symptoms * Self care skills (eg hygiene) | Behavioural | Control |
Primary outcome
Quality of life (with a quality of life scale specific to renal patients).
Time frame: 1st day of study
The KidneyDisease Quality of Life (KDQOL-36) consists of the SF-12, which measures physical and mental functioning, Burden of Kidney Disease subscale, Symptoms and Problems subscale, and Effects of Kidney Disease on Daily Life subscale. The scores of theKDQOL-36 questionnaire are transformed into 0 to 100, with higherscores indicating better quality of life.combines the generic SF-36 Health Survey instrument and disease-specific components for assessing the health-related quality of life of
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2019.
- Individual participant dataSharing planned: No
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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.
Özgü İnal principal investigator
Trakya 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 Awareness Training and Person-Centered Occupational Therapy Intervention and Awareness Training in people with Quality of Life, run by Hacettepe 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 3 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: status not confirmed, as of the sponsor's last update on 6 Aug 2019. 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?
Results are not available in the source record.
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?
Quality of life (with a quality of life scale specific to renal patients). (time frame: 1st day of study). 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 6 Aug 2019.