COPD III/IVTidal ModelNCT06760325
The Effect of a Tidal Model-Based Approach Applied During Home Visits on Mental Health Parameters and Hospital Admission Frequency in COPD Patients
A study testing Tidal Model Intervention in people with COPD III/IV, run by Kilis 7 Aralik University at 1 site in Turkey (Türkiye).
Trial summary
Despite the recent increased interest in identifying the needs of COPD patients and improving disease management, monitoring the psychosocial well-being of these individuals remains insufficient. Read more about this study
- Who is it for?
- Ages Up to 100 years
- Conditions the study is for
- COPD III/IV
- What is being tested?
- Tidal Model Intervention
- 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
- 29 May 2024to 29 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Up to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 18 years or older
- Clinical diagnosis of COPD for at least one year
- No cognitive or sensory disabilities
- No prior participation in any psychosocial support training
- GOLD stage 'E' COPD
- Availability of a private or suitable room for interviews
- Residence within the city center
Who cannot join
- Age under 18 years
- Declined participation in the study
- Cognitive or sensory disabilities
- Prior participation in any psychosocial support training
- GOLD stage 'A' or 'B' COPD
- Unsuitable environment for conducting interviews
- Security concerns for the researcher
- Residence outside the city center or in rural areas
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of a Tidal Model-Based Approach Applied During Home Visits on Mental Health Parameters and Hospital Admission Frequency in COPD Patients: a Randomized Controlled Trial
Despite the recent increased interest in identifying the needs of COPD patients and improving disease management, monitoring the psychosocial well-being of these individuals remains insufficient. Nursing care that incorporates psychosocial approaches plays a critical role in halting disease progression and controlling symptoms in COPD management. The Tidal Model emerges as a vital tool in enhancing patient independence throughout this process. This recovery-oriented model provides a robust framework for individualized care by thoroughly analyzing patients' needs. It likens life to an ocean voyage and emphasizes learning how to cope with challenges encountered during this journey. The difficulties experienced by individuals with chronic illness and respiratory limitations are aligned with the Tidal Model's concepts of chaos and tides.
Current studies indicate that psychological interventions for COPD patients have limited effectiveness in reducing psychological morbidity. Additionally, while interventions such as mindfulness-based and digital approaches show promise, their effects have not consistently proven significant across studies. This underscores the ongoing challenge of effectively addressing the psychological aspects of COPD and highlights the need for further research to identify more robust interventions.
In this context, guided by the philosophy of the Tidal Model that emphasizes "helping individuals with problems in living," it has been hypothesized that the model would be suitable for use with individuals with COPD. The current study aims to evaluate its effectiveness.
- Conditions
- COPD III/IV
- Being tested
- Tidal Model Intervention
- Keywords
- Tidal Model, COPD, Mental Health, Home Visits
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tidal Model InterventionBehavioural
The model emphasizes long-term developmental care, extending support from hospital to home after discharge. This approach equips individuals with skills to understand and address challenges, emphasizing therapeutic interventions and sustained support through professionals or community groups. By focusing on the "chaos" and "tide" concepts of the Tidal Model, psychosocial interventions aim to enhance independence, manage symptoms, and improve quality of life.
In this arm, Tidal Model-based approaches will be applied during home visits to COPD patients. Within the scope of the intervention, psychosocial needs of patients will be assessed, individualized care plans will be created and symptom management and independence will be promoted by focusing on the "chaos" and "tide" concepts of the Tidal Model.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm (No Intervention) | No intervention | In this arm, Tidal Model-based approaches will not be applied during home visits to COPD patients. No psychosocial interventions were provided to patients, and standard care was maintained. |
| Experimental Arm (Tidal Model Intervention) | Experimental | In this arm, Tidal Model-based psychosocial interventions will be applied during home visits to COPD patients. Receives: Behavioral: Tidal Model Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mental Well-being Score
The Warwick-Edinburgh Mental Well-being Scale was developed by Tennant and colleagues (2007) to measure the mental well-being levels of individuals in the United Kingdom. Encompassing both 'psychological well-being' and 'subjective well-being', the scale consists of 14 positive items. Higher scores on the scale indicate higher levels of mental well-being. The Warwick-Edinburgh Mental Well-being Scale Short Form (WEMWBS-SF) is a 7-item scale using a 5-point Likert scale (1=Never, 5=Always) and is composed of positive statements. This study opted for the short form. Participants were asked to consider their experiences over the past two weeks when completing the scale. The 7 items in the WEMWBS-SF are more closely related to functioning than to emotions. The validity and reliability of the WEMWBS-SF were examined in a sampl
Measured: Assessments will be conducted at three time points: baseline, post-intervention (after 7 weeks), and at the 19-week follow-up.
Quality of Life Score
The World Health Organization Quality of Life-BREF (WHOQOL-BREF) is a 26-item abbreviated version of the 100-item World Health Organization Quality of Life Assessment (WHOQOL), designed to evaluate an individual's perception of their quality of life. The scale is composed of four domains: general health, physical health, social relationships, and environment. The Turkish adaptation of the WHOQOL-BREF was conducted by Eser et al. (1999). The scale does not have a fixed total score; rather, an increase in score indicates an improvement in perceived quality of life.
Measured: Assessments will be conducted at three time points: baseline, post-intervention (after 7 weeks), and at the 19-week follow-up.
General Self-Efficacy Score
Originally developed in Germany in 1979 by Jerusalem and Schwarzer, the scale initially consisted of 20 items. In 1981, the same researchers revised the scale, reducing it to 10 items. In subsequent years, this four-point Likert-type scale (completely false = 1, completely true = 4) has been translated into numerous languages, and its validity and reliability have been extensively studied. Kaiser-Guttman eigenvalue and scree plot analyses have consistently indicated a single-factor solution across different countries. Subsequently, confirmatory factor analysis was conducted to test both one-factor and two-factor models. The results of confirmatory factor analysis supported the assumption of a single-factor structure. All items on the scale are positively scored, with a possible range of 10 to 40 points, and higher scores indicate higher levels of general self-efficacy. The Turkish adaptation and validation of the scale were conducted by Apay (2010).
Measured: Assessments will be conducted at three time points: baseline, post-intervention (after 7 weeks), and at the 19-week follow-up.
Self-Esteem Score
Developed by Rosenberg in 1965, the Rosenberg Self-Esteem Scale is a self-report measure originally composed of 63 multiple-choice items, divided into 12 subscales. For the purpose of measuring self-esteem, the first 10 items were selected for this study. Çuhadaroğlu (1986) conducted a Turkish adaptation and validation study, reporting a Cronbach's alpha of 0.81. The scale employs a four-point Likert format (strongly agree, agree, disagree, strongly disagree). Scoring involves assigning 4 points for "strongly agree" on positive items and 1 point for "strongly disagree," with the reverse scoring for negative items. The total score is calculated by summing the scores of the 10 items and dividing by 10. A higher average score indicates higher self-esteem.
Measured: Assessments will be conducted at three time points: baseline, post-intervention (after 7 weeks), and at the 19-week follow-up.
Visual Analog Scale for Anxiety
The Visual Analog Scale for Anxiety (VAS-A) is a simple yet effective method for assessing anxiety levels in patients. By providing a continuous 10 cm scale anchored by "no anxiety" and "highest possible anxiety," the VAS-A allows patients to subjectively rate their current anxiety.
Measured: Assessments will be conducted at three time points: baseline, post-intervention (after 7 weeks), and at the 19-week follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2025
- Study start29 May 2024
- Primary completion29 Aug 2024
- Study completion29 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD III/IVStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Interventional
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kilis 7 Aralik University
- Sponsor type
- University, hospital or other
- Collaborators
- Mersin University
- Responsible party
- Principal investigator, Özcan ÖZDEMİR, Kilis 7 Aralik University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06760325
- Sponsor's protocol ID
- 2024-OEM.1231
- Other IDs
- 2024-E.58302
- Acronym
- Tidal Model
- Status last verified
- Jan 2025
- First submitted
- 30 Dec 2024
- Last updated
- 8 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Tidal Model-Based Approach Applied During Home Visits on Mental Health Parameters and Hospital Admission Frequency in COPD Patients: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06760325
- Acronym / sponsor ID
- Tidal Model / 2024-OEM.1231
- Conditions
- COPD III/IV
- Keywords
- Tidal Model, COPD, Mental Health, Home Visits
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Kilis 7 Aralik UniversityUniversity, hospital or other
- Collaborators
- Mersin University
- Study start
- 29 May 2024 (actual)
- Primary completion
- 29 Aug 2024 (actual)
- Study completion
- 29 Aug 2025 (estimated)
- First posted
- 6 Jan 2025 (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.
Despite the recent increased interest in identifying the needs of COPD patients and improving disease management, monitoring the psychosocial well-being of these individuals remains insufficient. Nursing care that incorporates psychosocial approaches plays a critical role in halting disease progression and controlling symptoms in COPD management. The Tidal Model emerges as a vital tool in enhancing patient independence throughout this process. This recovery-oriented model provides a robust framework for individualized care by thoroughly analyzing patients' needs. It likens life to an ocean voyage and emphasizes learning how to cope with challenges encountered during this journey. The difficulties experienced by individuals with chronic illness and respiratory limitations are aligned with the Tidal Model's concepts of chaos and tides.
Current studies indicate that psychological interventions for COPD patients have limited effectiveness in reducing psychological morbidity. Additionally, while interventions such as mindfulness-based and digital approaches show promise, their effects have not consistently proven significant across studies. This underscores the ongoing challenge of effectively addressing the psychological aspects of COPD and highlights the need for further research to identify more robust interventions.
In this context, guided by the philosophy of the Tidal Model that emphasizes "helping individuals with problems in living," it has been hypothesized that the model would be suitable for use with individuals with COPD. The current study aims to evaluate its effectiveness.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Interventional
| Arm | Type | Receives |
|---|---|---|
| Control Arm (No Intervention) | No intervention | –In this arm, Tidal Model-based approaches will not be applied during home visits to COPD patients. No psychosocial interventions were provided to patients, and standard care was maintained. |
| Experimental Arm (Tidal Model Intervention) | Experimental | Behavioral: Tidal Model InterventionIn this arm, Tidal Model-based psychosocial interventions will be applied during home visits to COPD patients. |
Who may qualify
- Ages
- Up to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 years or older
- Clinical diagnosis of COPD for at least one year
- No cognitive or sensory disabilities
- No prior participation in any psychosocial support training
- GOLD stage 'E' COPD
Key exclusion criteria (8 listed)
- Age under 18 years
- Declined participation in the study
- Cognitive or sensory disabilities
- Prior participation in any psychosocial support training
- GOLD stage 'A' or 'B' COPD
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 InterventionThe model emphasizes long-term developmental care, extending support from hospital to home after discharge. This approach equips individuals with skills to understand and address challenges, emphasizing therapeutic interventions and sustained support through professionals or community groups. By focusing on the "chaos" and "tide" concepts of the Tidal Model, psychosocial interventions aim to enhance independence, manage symptoms, and improve quality of life. In this arm, Tidal Model-based approaches will be applied during home visits to COPD patients. Within the scope of the intervention, psychosocial needs of patients will be assessed, individualized care plans will be created and symptom management and independence will be promoted by focusing on the "chaos" and "tide" concepts of the Tidal Model. | Behavioural | Experimental Arm (Tidal Model Intervention) |
Primary outcome
Mental Well-being Score
Time frame: Assessments will be conducted at three time points: baseline, post-intervention (after 7 weeks), and at the 19-week follow-up.
The Warwick-Edinburgh Mental Well-being Scale was developed by Tennant and colleagues (2007) to measure the mental well-being levels of individuals in the United Kingdom. Encompassing both 'psychological well-being' and 'subjective well-being', the scale consists of 14 positive items. Higher scores on the scale indicate higher levels of mental well-being. The Warwick-Edinburgh Mental Well-being Scale Short Form (WEMWBS-SF) is a 7-item scale using a 5-point Likert scale (1=Never, 5=Always) and is composed of positive statements. This study opted for the short form. Participants were asked to consider their experiences over the past two weeks when completing the scale. The 7 items in the WEMWBS-SF are more closely related to functioning than to emotions. The validity and reliability of the WEMWBS-SF were examined in a sampl
Quality of Life Score
Time frame: Assessments will be conducted at three time points: baseline, post-intervention (after 7 weeks), and at the 19-week follow-up.
The World Health Organization Quality of Life-BREF (WHOQOL-BREF) is a 26-item abbreviated version of the 100-item World Health Organization Quality of Life Assessment (WHOQOL), designed to evaluate an individual's perception of their quality of life. The scale is composed of four domains: general health, physical health, social relationships, and environment. The Turkish adaptation of the WHOQOL-BREF was conducted by Eser et al. (1999). The scale does not have a fixed total score; rather, an increase in score indicates an improvement in perceived quality of life.
General Self-Efficacy Score
Time frame: Assessments will be conducted at three time points: baseline, post-intervention (after 7 weeks), and at the 19-week follow-up.
Originally developed in Germany in 1979 by Jerusalem and Schwarzer, the scale initially consisted of 20 items. In 1981, the same researchers revised the scale, reducing it to 10 items. In subsequent years, this four-point Likert-type scale (completely false = 1, completely true = 4) has been translated into numerous languages, and its validity and reliability have been extensively studied. Kaiser-Guttman eigenvalue and scree plot analyses have consistently indicated a single-factor solution across different countries. Subsequently, confirmatory factor analysis was conducted to test both one-factor and two-factor models. The results of confirmatory factor analysis supported the assumption of a single-factor structure. All items on the scale are positively scored, with a possible range of 10 to 40 points, and higher scores indicate higher levels of general self-efficacy. The Turkish adaptation and validation of the scale were conducted by Apay (2010).
Self-Esteem Score
Time frame: Assessments will be conducted at three time points: baseline, post-intervention (after 7 weeks), and at the 19-week follow-up.
Developed by Rosenberg in 1965, the Rosenberg Self-Esteem Scale is a self-report measure originally composed of 63 multiple-choice items, divided into 12 subscales. For the purpose of measuring self-esteem, the first 10 items were selected for this study. Çuhadaroğlu (1986) conducted a Turkish adaptation and validation study, reporting a Cronbach's alpha of 0.81. The scale employs a four-point Likert format (strongly agree, agree, disagree, strongly disagree). Scoring involves assigning 4 points for "strongly agree" on positive items and 1 point for "strongly disagree," with the reverse scoring for negative items. The total score is calculated by summing the scores of the 10 items and dividing by 10. A higher average score indicates higher self-esteem.
Visual Analog Scale for Anxiety
Time frame: Assessments will be conducted at three time points: baseline, post-intervention (after 7 weeks), and at the 19-week follow-up.
The Visual Analog Scale for Anxiety (VAS-A) is a simple yet effective method for assessing anxiety levels in patients. By providing a continuous 10 cm scale anchored by "no anxiety" and "highest possible anxiety," the VAS-A allows patients to subjectively rate their current anxiety.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2025.
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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.
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 Tidal Model Intervention in people with COPD III/IV, run by Kilis 7 Aralik 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 7 inclusion and 8 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: enrolling by invitation, as of the sponsor's last update on 8 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Mental Well-being Score (time frame: Assessments will be conducted at three time points: baseline, post-intervention (after 7 weeks), and at the 19-week follow-up.). The study lists 5 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 8 Jan 2025; AzTrials last refreshed its copy on 30 Oct 2026.