- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07640412
MPACT OF A HOME CARE GUIDE FOR DAILY LIVING ACTIVITIES ON STROKE CAREGIVERS' BURDEN AND EXPERIENCE
THE EFFECT OF A HOME CARE GUIDE DEVELOPED FOR ACTIVITIES OF DAILY LIVING ON THE CAREGIVER BURDEN AND EXPERIENCES OF STROKE PATIENT CAREGIVERS
The study aims to develop a home care guide, led by nurses, for stroke patients to maintain their activities of daily living, based on evidence-based current literature and guidelines, and to test the effect of this guide on caregiver burden. The results expected from this study are anticipated to contribute to the continuity of care in stroke patients, enhance self-care abilities through participation in daily activities, ensure adherence to treatment and care, control symptoms, reduce repeated hospitalizations, and improve the quality of life of caregivers by alleviating their caregiver burden.
The study was conducted in the home environment with caregivers of stroke patients registered at the Home Health Services unit of Sivas Numune Hospital.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
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Sivas, Turchia (Türkiye), 58000
- Sivas Numune Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
Inclusion Criteria:
- Individuals who have a patient diagnosed with stroke at least 6 months ago,
- Those who are in the position of providing continuous care,
- Those whose care recipients have a score below 60 on the Barthel Activities of Daily Living Index,
- Individuals who volunteer to participate in the study will be included in the study.
Exclusion Criteria:
- Individuals who have participated in a similar study in which training on home care for stroke patients was provided,
- Those who have physical, cognitive, or memory-related problems,
- Those whose care recipients have a score of 60 or above on the Barthel Activities of Daily Living Index,
- Individuals who do not agree to participate in the study will not be included in the study.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: HOME CARE GUIDE
The intervention group received training along with the developed home care guide, and pre-test, mid-test, and post-test were administered.
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The home care guide developed for activities of daily living was provided to the intervention group, and training related to it was delivered.
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Nessun intervento: Control Group
In the control group, pre-test and post-test were administered without any intervention.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Personal Information Form for Caregivers
Lasso di tempo: This intervention was applied to both the intervention and control groups during pre-testing conducted in weeks 0-4 of the study.
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It includes items such as the caregiver's demographic data (age, gender, marital status, number of children, education level, occupation, degree of relationship to the patient, income status), patient care experience, the presence of chronic diseases accompanying the stroke diagnosis, and the duration of caregiving.
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This intervention was applied to both the intervention and control groups during pre-testing conducted in weeks 0-4 of the study.
|
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Caregiver Burden Scale
Lasso di tempo: The intervention group was administered a pre-test (weeks 0-4), an intermediate test (weeks 5-8), and a post-test (weeks 9-12), while the control group received a pre-test (weeks 0-4) and a post-test (weeks 9-12).
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The scale consists of 22 items that determine the impact of caregiving on the lives of individuals who care for a person in need.
The scale is a Likert-type instrument ranging from 0 to 4, with the options 'never,' 'rarely,' 'sometimes,' 'quite frequently,' and 'almost always.'
The minimum score that can be obtained from the scale is 0 and the maximum score is 88.
The items in the scale generally focus on social and emotional aspects, and a higher total score indicates a higher level of distress experienced by the caregiver.
The scores are evaluated as follows: 0-20 indicates little or no burden, 21-40 indicates mild to moderate burden, 41-60 indicates moderate to severe burden, and 61-88 indicates severe burden.
The Cronbach's alpha reliability coefficient of the scale is 0.95.
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The intervention group was administered a pre-test (weeks 0-4), an intermediate test (weeks 5-8), and a post-test (weeks 9-12), while the control group received a pre-test (weeks 0-4) and a post-test (weeks 9-12).
|
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Bakas Caregiving Outcomes Scale
Lasso di tempo: The intervention group was administered a pre-test (weeks 0-4), an intermediate test (weeks 5-8), and a post-test (weeks 9-12), while the control group received a pre-test (weeks 0-4) and a post-test (weeks 9-12).
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The scale consists of 16 items and evaluates the positive and negative life changes experienced as a result of caregiving, ranging from the best direction (+3) to the worst direction (-3) (min.
15, max.
105).
The scale has no subdimensions.
As the total score obtained from the scale increases, it indicates a 'positive change,' while a decrease in the score indicates a 'negative change.'
The Turkish validity and reliability study of the scale was conducted by Can and Cavlak in 2010.
In that study, the internal consistency coefficient of the scale was found to be 0.90, and the test-retest reliability was 0.961.
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The intervention group was administered a pre-test (weeks 0-4), an intermediate test (weeks 5-8), and a post-test (weeks 9-12), while the control group received a pre-test (weeks 0-4) and a post-test (weeks 9-12).
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Collaboratori e investigatori
Sponsor
Investigatori
- Direttore dello studio: MUKADDER MOLLAOĞLU, Prof.Dr., Cumhuriyet University
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2024-12/43
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Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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