DiabeticNCT05994651
The Effect of the Tidal Model in Diabetes Patients
A study testing Tidal Model improvement model in people with Diabetic, run by Osmaniye Korkut Ata University at 1 site in Turkey (Türkiye).
Trial summary
Aim: In this study, it was aimed to evaluate the effect of the tidal model on distress, self-management and psychological well-being in individuals with diabetes. It is thought that this study will contribute to the literature, nursing profession and patients with diabetes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetic
- What is being tested?
- Tidal Model improvement model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jul 2023to 10 Sep 2023
- 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
- Diagnosed with diabetes for at least 6 months, Individuals aged 18 and over will be included in the study.
Who cannot join
- Patients with any psychiatric or neurological disorder that would prevent adequate communication will not be included in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Türkiye
Osmaniye, Korkut Ata University, 80000
About this study
Official title: Evaluation of the Effect of Tidal Model on Distress, Self-Management and Psychological Well-Being in Individuals With Diabetes
Aim:
In this study, it was aimed to evaluate the effect of the tidal model on distress, self-management and psychological well-being in individuals with diabetes. It is thought that this study will contribute to the literature, nursing profession and patients with diabetes.
Read the detailed description
Population of the Research: The population of the research will be individuals who applied to Osmaniye State Hospital and were diagnosed with Diabetes at least 6 months ago. The sample of the research: The sample of the research is; In calculating the number of samples, the study of Savaşan and Çam named 'The Effect of the Psychiatric Nursing Approach Based on the Tidal Model on Coping and Self-esteem in People with Alcohol Dependency: A Randomized Trial' was taken as reference.At the end of the Tidal Model application, the effect size was calculated as 0.652 based on the difference between the self-esteem scores. In this context; A power of 0.80 and a margin of error of 0.05 for type 1 were taken, and it was deemed appropriate to take a total of 60 individuals, with a sample size of 30 individuals in the intervention and control groups. Sample size is based on independent t-test. It was decided to include more than 20% of the sample number calculated in terms of losses during the implementation of the study and statistical analysis. Accordingly, 36 intervention and 36 control groups will beResearch data
Literature-based Personal Information Form will be collected using Diabetes Distress Scale Type 2 Diabetes Self-Management Scale Psychological Well-Being Scale. In order to conduct the study, the approval of the Clinical Research Ethics Committee, written permission from the institution and written permission from the participants were obtained.In the study, in which the psychiatric nursing approach based on the Tidal Model is applied, approximately 6 and 10 individual interviews will be held with the individuals in the experimental group in addition to the routine treatment and follow-up in the Osmaniye State Hospital training hall. The control group will continue to receive routine treatment and follow-up. In order to provide individualized care to the individuals in the experimental group, initiatives will be implemented by starting individual interviews and in line with the goals of the individuals and the objectives of the research. Considering the basic processes of the Tidal Model, stages of care, basic approach and Tidal competencies, an interview plan including the details of the interviews with diabetes patients will be created and a meeting plan will be made with One-to-One Sessions. It will be concluded with an average of 6 and 10 interviews, depending on the situation of the individuals. tried to be formed. The number of samples was calculated in the G*Power 3.1 program.
- Conditions
- Diabetic
- Being tested
- Tidal Model improvement model
- Keywords
- Diabetes disease, Psychiatric Nursing, Tidal Model, Psychological well-being, Distress, Self-Management
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tidal Model improvement modelBehavioural
- st interview Pre-assessment Application of measurement tools
- nd meeting Orientation Concept of recovery, change phase of the individual, Holistic Evaluation, Creation of Personal Safety Plan 3. Interview Process planning Setting goals, Starting One-on-One Sessions
4th meeting Healing is possible, accepting his illness, overcoming change, emphasizing his strengths, instilling hope 5.-6. interview Empowerment Coping with crisis, reducing anxiety, relaxation exercises, individual roles, assertiveness, strengthening self-esteem 7.-8. Interview Maintaining control of life, taking responsibility for behavior, appropriate expression of anger, feeling, thinking and Taking responsibility for recovery, discovering behaviors 9th interview Creating a supportive environment Increasing new interactions, relationships, social skills 10th meeting Evaluation Finalizing the personal security plan, using new knowledge and behaviors in the healing journey, evaluation of the process
| Study group | Role | What they receive |
|---|---|---|
| Tidal Model improvement model | Experimental | In order to provide individualized care to the individuals in the experimental group, initiatives will be implemented by starting individual interviews and in line with the goals of the individuals and the research objectives. Receives: Behavioral: Tidal Model improvement model |
| Tidal Model Control Group | No intervention | Individuals in the control group will continue their lives. |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. The effect of using the tidal model on the distress status of individuals with diabetes will be evaluated.
The DDS is a 17-item psychological measurement tool that uses a Likert scale with each item scored from 1 (no distress) to 6 (serious distress) to reflect distress experienced over the last month. The total score is calculated by dividing the sum of the answers by 17. A score of ≥3 is defined as T2DM-related distress. There are four subscales and subscale scores are also calculated by dividing the sum of subscale answers to the total question count of the subscale. Subscales are as follows: the emotional burden subscale with 5 questions, the physician-related distress subscale with 4 questions, the regimen-related distress subscale with 5 questions, and the interpersonal distress subscale with 3 questions.
Measured: up to 6-10 weeks
The effect of using the tidal model on the self-management status of individuals with diabetes will be evaluated.
There are 8 items in the original scale of the Diabetes Self-Management Perception Scale. High participation in these items indicates low self-efficacy. For this reason, the 3 items mentioned were reverse scored compared to the other items. The lowest score that can be obtained from the scale is 7, and the highest score is 35. A high total score indicates that the individual has good awareness of diabetes management
Measured: up to 6-10 weeks
The effect of using the tidal model on the psychological well-being of individuals with diabetes will be evaluated.
The scale is an 8-item 7-point Likert-type (1=totally disagree, 7=totally agree) self-assessment scale. High scores indicate higher psychological well-being.
Measured: up to 6-10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2023
- Study start10 Jul 2023
- Primary completion10 Jul 2023
- Study completion10 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabeticStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Osmaniye Korkut Ata University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ejdane Coskun, Osmaniye Korkut Ata University
- Investigators
- Ejdane Coşkun, Principal investigator, Korkut Ata University Osmaniye, Center, Türkiye, 80000Ayşe İNEL MANAV, Principal investigator, Korkut Ata University Osmaniye, Center, Türkiye, 80000Derya Atik, Principal investigator, Korkut Ata University Osmaniye, Center, Türkiye, 80000
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05994651
- Sponsor's protocol ID
- Tidal Model
- Status last verified
- Oct 2023
- First submitted
- 8 Aug 2023
- Last updated
- 1 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Don't share
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Tidal Model on Distress, Self-Management and Psychological Well-Being in Individuals With Diabetes
- ClinicalTrials.gov ID
- NCT05994651
- Acronym / sponsor ID
- Tidal Model
- Conditions
- Diabetic
- Keywords
- Diabetes disease, Psychiatric Nursing, Tidal Model, Psychological well-being, Distress, Self-Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Osmaniye Korkut Ata UniversityUniversity, hospital or other
- Study start
- 10 Jul 2023 (actual)
- Primary completion
- 10 Jul 2023 (actual)
- Study completion
- 10 Sep 2023 (actual)
- First posted
- 16 Aug 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.
Aim:
In this study, it was aimed to evaluate the effect of the tidal model on distress, self-management and psychological well-being in individuals with diabetes. It is thought that this study will contribute to the literature, nursing profession and patients with diabetes.
Detailed description
Population of the Research: The population of the research will be individuals who applied to Osmaniye State Hospital and were diagnosed with Diabetes at least 6 months ago. The sample of the research: The sample of the research is; In calculating the number of samples, the study of Savaşan and Çam named 'The Effect of the Psychiatric Nursing Approach Based on the Tidal Model on Coping and Self-esteem in People with Alcohol Dependency: A Randomized Trial' was taken as reference.At the end of the Tidal Model application, the effect size was calculated as 0.652 based on the difference between the self-esteem scores. In this context; A power of 0.80 and a margin of error of 0.05 for type 1 were taken, and it was deemed appropriate to take a total of 60 individuals, with a sample size of 30 individuals in the intervention and control groups. Sample size is based on independent t-test. It was decided to include more than 20% of the sample number calculated in terms of losses during the implementation of the study and statistical analysis. Accordingly, 36 intervention and 36 control groups will beResearch data
Literature-based Personal Information Form will be collected using Diabetes Distress Scale Type 2 Diabetes Self-Management Scale Psychological Well-Being Scale. In order to conduct the study, the approval of the Clinical Research Ethics Committee, written permission from the institution and written permission from the participants were obtained.In the study, in which the psychiatric nursing approach based on the Tidal Model is applied, approximately 6 and 10 individual interviews will be held with the individuals in the experimental group in addition to the routine treatment and follow-up in the Osmaniye State Hospital training hall. The control group will continue to receive routine treatment and follow-up. In order to provide individualized care to the individuals in the experimental group, initiatives will be implemented by starting individual interviews and in line with the goals of the individuals and the objectives of the research. Considering the basic processes of the Tidal Model, stages of care, basic approach and Tidal competencies, an interview plan including the details of the interviews with diabetes patients will be created and a meeting plan will be made with One-to-One Sessions. It will be concluded with an average of 6 and 10 interviews, depending on the situation of the individuals. tried to be formed. The number of samples was calculated in the G*Power 3.1 program.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tidal Model improvement model | Experimental | Behavioral: Tidal Model improvement modelIn order to provide individualized care to the individuals in the experimental group, initiatives will be implemented by starting individual interviews and in line with the goals of the individuals and the research objectives. |
| Tidal Model Control Group | No intervention | –Individuals in the control group will continue their lives. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosed with diabetes for at least 6 months, Individuals aged 18 and over will be included in the study.
Key exclusion criteria (1 listed)
- Patients with any psychiatric or neurological disorder that would prevent adequate communication will not be included in the study.
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 |
|---|---|---|
| Tidal Model improvement model1. st interview Pre-assessment Application of measurement tools 2. nd meeting Orientation Concept of recovery, change phase of the individual, Holistic Evaluation, Creation of Personal Safety Plan 3. Interview Process planning Setting goals, Starting One-on-One Sessions 4th meeting Healing is possible, accepting his illness, overcoming change, emphasizing his strengths, instilling hope 5.-6. interview Empowerment Coping with crisis, reducing anxiety, relaxation exercises, individual roles, assertiveness, strengthening self-esteem 7.-8. Interview Maintaining control of life, taking responsibility for behavior, appropriate expression of anger, feeling, thinking and Taking responsibility for recovery, discovering behaviors 9th interview Creating a supportive environment Increasing new interactions, relationships, social skills 10th meeting Evaluation Finalizing the personal security plan, using new knowledge and behaviors in the healing journey, evaluation of the process | Behavioural | Tidal Model improvement model |
Primary outcome
1. The effect of using the tidal model on the distress status of individuals with diabetes will be evaluated.
Time frame: up to 6-10 weeks
The DDS is a 17-item psychological measurement tool that uses a Likert scale with each item scored from 1 (no distress) to 6 (serious distress) to reflect distress experienced over the last month. The total score is calculated by dividing the sum of the answers by 17. A score of ≥3 is defined as T2DM-related distress. There are four subscales and subscale scores are also calculated by dividing the sum of subscale answers to the total question count of the subscale. Subscales are as follows: the emotional burden subscale with 5 questions, the physician-related distress subscale with 4 questions, the regimen-related distress subscale with 5 questions, and the interpersonal distress subscale with 3 questions.
The effect of using the tidal model on the self-management status of individuals with diabetes will be evaluated.
Time frame: up to 6-10 weeks
There are 8 items in the original scale of the Diabetes Self-Management Perception Scale. High participation in these items indicates low self-efficacy. For this reason, the 3 items mentioned were reverse scored compared to the other items. The lowest score that can be obtained from the scale is 7, and the highest score is 35. A high total score indicates that the individual has good awareness of diabetes management
The effect of using the tidal model on the psychological well-being of individuals with diabetes will be evaluated.
Time frame: up to 6-10 weeks
The scale is an 8-item 7-point Likert-type (1=totally disagree, 7=totally agree) self-assessment scale. High scores indicate higher psychological well-being.
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 Nov 2023.
- Individual participant dataSharing planned: No. Don't 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.
Ejdane Coşkun principal investigator
Korkut Ata University Osmaniye, Center, Türkiye, 80000
Ayşe İNEL MANAV principal investigator
Korkut Ata University Osmaniye, Center, Türkiye, 80000
Derya Atik principal investigator
Korkut Ata University Osmaniye, Center, Türkiye, 80000
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tidal Model improvement model in people with Diabetic, run by Osmaniye Korkut Ata 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 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 1 Nov 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?
1. The effect of using the tidal model on the distress status of individuals with diabetes will be evaluated. (time frame: up to 6-10 weeks). The study lists 3 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 Nov 2023.