- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
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Sivas, Tyrkia (Türkiye), 58000
- Sivas Numune Hospital
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Aktiv komparator: 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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Ingen inngripen: Control Group
In the control group, pre-test and post-test were administered without any intervention.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Personal Information Form for Caregivers
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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).
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: MUKADDER MOLLAOĞLU, Prof.Dr., Cumhuriyet University
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2024-12/43
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