Hemodialysis PatientNCT05955703
Evaluation of the Effect of the Training Program Based on the Precede-Proceed Model on Guality Life Style
A study testing ppm based training in people with Hemodialysis Patient, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted to evaluate the effect of a Precede-Proceed Model-based (PPM-based) training program on treatment adherence, healthy lifestyle behaviors, and quality of life of hemodialysis patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hemodialysis Patient
- What is being tested?
- ppm based training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Oct 2021to 8 Dec 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older,
- Hemodialysis treatment for at least 6 months,
- A total score of 1 or more from the Dialysis Diet and Fluid Restriction Non-Compliance Scale,
- A score between 1 and 7 on the scale of compliance with medical treatment,
- Place, time, person orientation,
- Does not have a psychiatric illness or a problem that prevents written or verbal communication,
Who cannot join
- Diagnosed with psychiatric illness Individuals with a diagnosis of malignancy wanting to leave research
- Those who do not attend all of the trainings / do not want to continue
- Individuals whose general condition is deteriorated
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effect of the Training Program Based on the Precede-Proceed Model on Adherence to Treatment and Healthy Lifestyle Behaviors of Hemodialysis Patients
This study was conducted to evaluate the effect of a Precede-Proceed Model-based (PPM-based) training program on treatment adherence, healthy lifestyle behaviors, and quality of life of hemodialysis patients.
Read the detailed description
The Precede proceed model includes structured training phases to bring positive behavior change. The model, which consists of training phases, provides the researcher with the opportunity to identify the problem and the deficiencies that cause the problem, evaluate the quality of life with these deficiencies and develop a health program for its solution. In order to apply the nine-phase model, the individual-patient's voluntary cooperation, determination and active participation in health practices are required.
- Conditions
- Hemodialysis Patient
- Being tested
- ppm based training
- Keywords
- Adherence to treatment, healthy lifestyle behavior, hemodialysis, nursing, precede-proceed model, quality of life
- Medical subject headings
- Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ppm based trainingBehavioural
The training program based on the precede proceed model was applied to hemodialysis patients for 8 sessions. Eight sessions of training were given to the experimental group within the scope of the model, a booklet was developed in line with the trainings and posters were prepared.
| Study group | Role | What they receive |
|---|---|---|
| Using the experimental group as a result of the training based on PPM | Experimental | The training sessions planned within the scope of PPM were applied to the patients, who were divided into groups of six according to the bed order, for 15-20 minutes for eight weeks, when the patients felt well, through training booklets and power point presentations. When the trainings started, the posters prepared were hung in the waiting room while the intervention group was undergoing hemodialysis. The person providing the care of the patient was included in each training. During the trainings, it was requested that the training booklets be with the patients and the power point presentations continued in parallel with the training booklets.
* Post-test was applied to intervention group
* three months after the post-test application, follow-up test was applied to the intervention group in order to evaluate the impact. Receives: Behavioral: ppm based training |
| Using the control group as a result of the training based on PPM | No intervention | After the follow-up test, training was given to the patients in the control group and a model-based training booklet was distributed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the Effect of the Training Program based on the Precede-Proceed Model on quality of life style of Hemodialysis Patients
The patients' quality of life was evaluated with the SF-12 Quality of Life scale. The scale consists of 12 items. There is no breakpoint. The higher the score obtained from the scale, the higher the quality of life.
Measured: six month
Secondary outcomes (1)
2. Evaluation of the Effects of the Continuation Test (follow-up test results 3 months after the post-test) and the Education Program Based on the Pre-Continuation Model on the Quality of Life of Hemodialysis Patients
The patients' quality of life was evaluated with the SF-12 Quality of Life scale. The scale consists of 12 items. There is no breakpoint. The higher the score obtained from the scale, the higher the quality of life.
Measured: three month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2023
- Study start18 Oct 2021
- Primary completion8 Dec 2022
- Study completion8 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodialysis PatientStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşenur SARIASLAN, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05955703
- Sponsor's protocol ID
- AYSENUR-TEZ
- Status last verified
- Jul 2023
- First submitted
- 1 Jun 2023
- Last updated
- 21 Jul 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 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of the Training Program Based on the Precede-Proceed Model on Adherence to Treatment and Healthy Lifestyle Behaviors of Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT05955703
- Acronym / sponsor ID
- AYSENUR-TEZ
- Conditions
- Hemodialysis Patient
- Keywords
- Adherence to treatment, healthy lifestyle behavior, hemodialysis, nursing, precede-proceed model, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 18 Oct 2021 (actual)
- Primary completion
- 8 Dec 2022 (actual)
- Study completion
- 8 Dec 2022 (actual)
- First posted
- 21 Jul 2023 (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.
This study was conducted to evaluate the effect of a Precede-Proceed Model-based (PPM-based) training program on treatment adherence, healthy lifestyle behaviors, and quality of life of hemodialysis patients.
Detailed description
The Precede proceed model includes structured training phases to bring positive behavior change. The model, which consists of training phases, provides the researcher with the opportunity to identify the problem and the deficiencies that cause the problem, evaluate the quality of life with these deficiencies and develop a health program for its solution. In order to apply the nine-phase model, the individual-patient's voluntary cooperation, determination and active participation in health practices are required.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Using the experimental group as a result of the training based on PPM | Experimental | Behavioral: ppm based trainingThe training sessions planned within the scope of PPM were applied to the patients, who were divided into groups of six according to the bed order, for 15-20 minutes for eight weeks, when the patients felt well, through training booklets and power point presentations. When the trainings started, the posters prepared were hung in the waiting room while the intervention group was undergoing hemodialysis. The person providing the care of the patient was included in each training. During the trainings, it was requested that the training booklets be with the patients and the power point presentations continued in parallel with the training booklets. * Post-test was applied to intervention group * three months after the post-test application, follow-up test was applied to the intervention group in order to evaluate the impact. |
| Using the control group as a result of the training based on PPM | No intervention | –After the follow-up test, training was given to the patients in the control group and a model-based training booklet was distributed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years of age or older,
- Hemodialysis treatment for at least 6 months,
- A total score of 1 or more from the Dialysis Diet and Fluid Restriction Non-Compliance Scale,
- A score between 1 and 7 on the scale of compliance with medical treatment,
- Place, time, person orientation,
Key exclusion criteria (3 listed)
- Diagnosed with psychiatric illness Individuals with a diagnosis of malignancy wanting to leave research
- Those who do not attend all of the trainings / do not want to continue
- Individuals whose general condition is deteriorated
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 |
|---|---|---|
| ppm based trainingThe training program based on the precede proceed model was applied to hemodialysis patients for 8 sessions. Eight sessions of training were given to the experimental group within the scope of the model, a booklet was developed in line with the trainings and posters were prepared. | Behavioural | Using the experimental group as a result of the training based on PPM |
Primary outcome
Evaluation of the Effect of the Training Program based on the Precede-Proceed Model on quality of life style of Hemodialysis Patients
Time frame: six month
The patients' quality of life was evaluated with the SF-12 Quality of Life scale. The scale consists of 12 items. There is no breakpoint. The higher the score obtained from the scale, the higher the quality of life.
1 secondary outcome
2. Evaluation of the Effects of the Continuation Test (follow-up test results 3 months after the post-test) and the Education Program Based on the Pre-Continuation Model on the Quality of Life of Hemodialysis Patients
Time frame: three month
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 21 Jul 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ppm based training in people with Hemodialysis Patient, run by Ataturk 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 6 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 21 Jul 2023. 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?
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?
Evaluation of the Effect of the Training Program based on the Precede-Proceed Model on quality of life style of Hemodialysis Patients (time frame: six month). 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 21 Jul 2023.