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Completed

NCT Number: NCT07640412

MPACT OF A HOME CARE GUIDE FOR DAILY LIVING ACTIVITIES ON STROKE CAREGIVERS' BURDEN AND EXPERIENCE

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sivas Numune Hospital

Sivas, 58000, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Training and Materials

Other

The home care guide developed for activities of daily living was provided to the intervention group, and training related to it was delivered.

Primary outcomes

  1. Personal Information Form for Caregivers

    Time frame: This intervention was applied to both the intervention and control groups during pre-testing conducted in weeks 0-4 of the study.

    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.

  2. Caregiver Burden Scale

    Time frame: 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).

    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.

  3. Bakas Caregiving Outcomes Scale

    Time frame: 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).

    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.

Sponsors and collaborators

Lead sponsor

Cumhuriyet University

Other

Registry information

Official study title

THE EFFECT OF A HOME CARE GUIDE DEVELOPED FOR ACTIVITIES OF DAILY LIVING ON THE CAREGIVER BURDEN AND EXPERIENCES OF STROKE PATIENT CAREGIVERS

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 10, 2026
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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