OutpatientsNCT05959993
Human Care Model-Based Nursing Interventions on Psychosocial Adjustment
A study testing Human Care Model Based Nursing Interventions in people with Outpatients and Defibrillators, Implantable, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the randomized controlled interventional study was to to evaluate the effect of human care model-based nursing interventions on psychosocial adaptation in patients with cardioverter defibrillator. A study was carried out on a sample of 64 patients who had been implanted with a defibrillator. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Outpatients, Defibrillators, Implantable
- What is being tested?
- Human Care Model Based Nursing Interventions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2020to 7 Jul 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
- the patient must be of legal age
- the patient must have undergone ICD implantation at least one month prior
- the patient must possess the ability to comprehend and communicate in Turkish
- the patient must not exhibit any hearing or speech impairments
- the patient must not have received a medical diagnosis of a neurological or psychiatric condition that may impact cognitive function, such as Alzheimer's or schizophrenia
- the patient must possess the capability to operate a computer, telephone, and internet
Who cannot join
- the patient is less than 18 years old
- the patient has hearing and speech problems
- the patient must have received a medical diagnosis of a neurological or psychiatric condition that may impact cognitive function, such as Alzheimer's or schizophrenia
- the patient must not possess the capability to operate a computer, telephone, and internet
- the patient's refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Human Care Model-Based Nursing Interventions on Psychosocial Adjustment in Patients With Cardioverter Defibrillator
The aim of the randomized controlled interventional study was to to evaluate the effect of human care model-based nursing interventions on psychosocial adaptation in patients with cardioverter defibrillator. A study was carried out on a sample of 64 patients who had been implanted with a defibrillator. The intervention group participants underwent six interviews at two-week intervals, during which a hybrid and structured nursing intervention was administered.
Read the detailed description
Aim: The aim of this research was to investigate the impact of nursing interventions that were Watson's Human Care Model- based nursing interventions on the psychosocial adjustment of patients who have undergone implantable cardioverter defibrillator (ICD) implantation.
Design: The present study employs a randomized controlled design with a pretest-posttest control group, conducted over a period spanning from March 2020 to July 2022.
Methods: The research was carried out utilizing an implantable cardioverter on individuals who met the inclusion criteria and provided consent to participate in the study at an adult cardiology outpatient unit located within a university hospital. A study was carried out on a sample of 64 patients who had been implanted with a defibrillator. The intervention group participants underwent six interviews at two-week intervals, during which a hybrid and structured nursing intervention was administered. The data were gathered utilizing an introductory information form and the Psychosocial Adjustment to Illness-Self-Report Scale (PAIS-SR). The statistical methods employed in the data analysis included the chi-square test, t test for independent groups, Mann-Whitney U test, t test for dependent groups, and Wilcoxon signed-rank test.
- Conditions
- Outpatients, Defibrillators, Implantable
- Being tested
- Human Care Model Based Nursing Interventions
- Keywords
- Defibrillator, Human Care Model, Psychosocial Adjustment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human Care Model Based Nursing InterventionsBehavioural
The interviews scheduled for the intervention group were organized in accordance with the sub-dimensions of the PAIS-SR scale, and the content of each interview was informed by the 10 improvement processes of HCT.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Intervention group participants underwent six interviews at two-week intervals, during which a hybrid and structured nursing intervention was administered. Receives: Behavioral: Human Care Model Based Nursing Interventions |
| Control group | No intervention | Control group participants were not subjected to a structured nursing intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increasing the patient's psychosocial adjustment with ICD
Psychosocial Adjustment to Illness Scale -Self Report (PAIS-SR) scale was used. This scale is a multidimensional scale that evaluates psychosocial adjustment to the disease. There are 7 different subscales of the scale that enable the determination of psychosocial adjustment, and the scale consists of a total of 46 items. These subscales are as follows; Orientation to Healthcare, Vocational Environment, Domestic Environment, Sexual Relationships, Extended family Relationships, Social Environment and Psychological distress. The minimum and maximum scores obtained from the scale are between 0-138. The higher the score, the worse the fit. Scores below 35 from the scale indicate good psychosocial adjustment, scores between 35-51 indicate moderately good psychosocial adjustment, and scores above 51 indicate poor adjustment.
Measured: 10 week later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2023
- Study start1 Mar 2020
- Primary completion23 Jan 2021
- Study completion7 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OutpatientsStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozgur Demir Gayretli, Ege University
- Investigators
- Serap Yıldırım, Associate Professor, Study director, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05959993
- Sponsor's protocol ID
- ODGayretli
- Status last verified
- Jul 2023
- First submitted
- 31 May 2023
- Last updated
- 1 Aug 2023
- 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 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Human Care Model-Based Nursing Interventions on Psychosocial Adjustment in Patients With Cardioverter Defibrillator
- ClinicalTrials.gov ID
- NCT05959993
- Acronym / sponsor ID
- ODGayretli
- Conditions
- Outpatients, Defibrillators, Implantable
- Keywords
- Defibrillator, Human Care Model, Psychosocial Adjustment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 23 Jan 2021 (actual)
- Study completion
- 7 Jul 2022 (actual)
- First posted
- 25 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.
The aim of the randomized controlled interventional study was to to evaluate the effect of human care model-based nursing interventions on psychosocial adaptation in patients with cardioverter defibrillator. A study was carried out on a sample of 64 patients who had been implanted with a defibrillator. The intervention group participants underwent six interviews at two-week intervals, during which a hybrid and structured nursing intervention was administered.
Detailed description
Aim: The aim of this research was to investigate the impact of nursing interventions that were Watson's Human Care Model- based nursing interventions on the psychosocial adjustment of patients who have undergone implantable cardioverter defibrillator (ICD) implantation.
Design: The present study employs a randomized controlled design with a pretest-posttest control group, conducted over a period spanning from March 2020 to July 2022.
Methods: The research was carried out utilizing an implantable cardioverter on individuals who met the inclusion criteria and provided consent to participate in the study at an adult cardiology outpatient unit located within a university hospital. A study was carried out on a sample of 64 patients who had been implanted with a defibrillator. The intervention group participants underwent six interviews at two-week intervals, during which a hybrid and structured nursing intervention was administered. The data were gathered utilizing an introductory information form and the Psychosocial Adjustment to Illness-Self-Report Scale (PAIS-SR). The statistical methods employed in the data analysis included the chi-square test, t test for independent groups, Mann-Whitney U test, t test for dependent groups, and Wilcoxon signed-rank test.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Human Care Model Based Nursing InterventionsIntervention group participants underwent six interviews at two-week intervals, during which a hybrid and structured nursing intervention was administered. |
| Control group | No intervention | –Control group participants were not subjected to a structured nursing intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- the patient must be of legal age
- the patient must have undergone ICD implantation at least one month prior
- the patient must possess the ability to comprehend and communicate in Turkish
- the patient must not exhibit any hearing or speech impairments
- the patient must not have received a medical diagnosis of a neurological or psychiatric condition that may impact cognitive function, such as Alzheimer's or schizophrenia
Key exclusion criteria (5 listed)
- the patient is less than 18 years old
- the patient has hearing and speech problems
- the patient must have received a medical diagnosis of a neurological or psychiatric condition that may impact cognitive function, such as Alzheimer's or schizophrenia
- the patient must not possess the capability to operate a computer, telephone, and internet
- the patient's refusal to participate 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 |
|---|---|---|
| Human Care Model Based Nursing InterventionsThe interviews scheduled for the intervention group were organized in accordance with the sub-dimensions of the PAIS-SR scale, and the content of each interview was informed by the 10 improvement processes of HCT. | Behavioural | Intervention group |
Primary outcome
Increasing the patient's psychosocial adjustment with ICD
Time frame: 10 week later
Psychosocial Adjustment to Illness Scale -Self Report (PAIS-SR) scale was used. This scale is a multidimensional scale that evaluates psychosocial adjustment to the disease. There are 7 different subscales of the scale that enable the determination of psychosocial adjustment, and the scale consists of a total of 46 items. These subscales are as follows; Orientation to Healthcare, Vocational Environment, Domestic Environment, Sexual Relationships, Extended family Relationships, Social Environment and Psychological distress. The minimum and maximum scores obtained from the scale are between 0-138. The higher the score, the worse the fit. Scores below 35 from the scale indicate good psychosocial adjustment, scores between 35-51 indicate moderately good psychosocial adjustment, and scores above 51 indicate poor adjustment.
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 Aug 2023.
- 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.
Serap Yıldırım, Associate Professor study director
Ege 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 Human Care Model Based Nursing Interventions in people with Outpatients and Defibrillators, Implantable, run by Ege 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 5 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 Aug 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?
Increasing the patient's psychosocial adjustment with ICD (time frame: 10 week later). 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 Aug 2023.