Clinical trial NCT06760325: The Effect of a Tidal Model-Based Approach Applied During Home Visits on Mental Health Parameters and Hospital Admission Frequency in COPD Patients
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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: COPD III/IV
Keywords: Tidal Model
COPD
Mental Health
Home Visits
Lead sponsor: Kilis 7 Aralik University
Sponsor class: OTHER
Collaborators: name: Mersin University
First posted: 2025-01-06
Enrollment: 42
Sex: ALL
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Interventional
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Mental Well-being Score
timeFrame: Assessments will be conducted at three time points: baseline, post-intervention (after 7 weeks), and at the 19-week follow-up.
measure: Quality of Life Score
timeFrame: Assessments will be conducted at three time points: baseline, post-intervention (after 7 weeks), and at the 19-week follow-up.
measure: General Self-Efficacy Score
timeFrame: Assessments will be conducted at three time points: baseline, post-intervention (after 7 weeks), and at the 19-week follow-up.
measure: Self-Esteem Score
timeFrame: Assessments will be conducted at three time points: baseline, post-intervention (after 7 weeks), and at the 19-week follow-up.
measure: Visual Analog Scale for Anxiety
timeFrame: Assessments will be conducted at three time points: baseline, post-intervention (after 7 weeks), and at the 19-week follow-up.
Secondary outcomes:
Other outcomes:
Locations:
city: Ki̇li̇s
country: Turkey
facility: Kilis 7 Aralık Üniversitesi
Study officials:
References: