NCT05901909

Brief Summary

Although stroke home care patients receive various treatments, they generally continue their lives as semi-dependent or fully dependent. Considering that stroke patients are especially elderly individuals, it is seen that they receive home health services and need a caregiver. The caregiver feels themselves under a heavy burden due to the lack of knowledge and insufficient experience. In addition, the lack of social support levels and the lack of training in patient care cause negative effects on patient outcomes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 22, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

June 13, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

July 13, 2023

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 18, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 18, 2023

Completed
Last Updated

December 11, 2024

Status Verified

December 1, 2024

Enrollment Period

5 days

First QC Date

May 22, 2023

Last Update Submit

December 6, 2024

Conditions

Keywords

StrokeHome Care ServicesCaregiversSocial SupportPatient-Relevant Outcome

Outcome Measures

Primary Outcomes (3)

  • Patient Evaluation Form

    It is intended to evaluate the following findings. In this evaluation form: Presence of urinary catheter ()yes ()no, the last date of admission to the health institution, the status of applying to the health institution due to infection recently ()yes ()no, presence of pressure sores in the patient ()no, ()stage 1, ()stage 2, ()stage 3, ()stage 4, the patient's diet ()oral ()enteral ()parenteral, presence of constipation-diarrhea in the patient ()yes ()no, presence of incontinence in the patient ()yes () no, dementia status ()yes ()no, risk of falling ()yes ()no

    In the first week after the start of the study, home visits will be made and the patients will be evaluated through the patient evaluation form.

  • Patient Evaluation Form

    It is intended to evaluate the following findings. In this evaluation form: Presence of urinary catheter ()yes ()no, the last date of admission to the health institution, the status of applying to the health institution due to infection recently ()yes ()no, presence of pressure sores in the patient ()no, ()stage 1, ()stage 2, ()stage 3, ()stage 4, the patient's diet ()oral ()enteral ()parenteral, presence of constipation-diarrhea in the patient ()yes ()no, presence of incontinence in the patient ()yes () no, dementia status ()yes ()no, risk of falling ()yes ()no

    After the training program reaches all of the caregivers in the determined number and the training is completed, the first evaluation will be made for the patient in the 8th week.

  • Patient Evaluation Form

    It is intended to evaluate the following findings. In this evaluation form: Presence of urinary catheter ()yes ()no, the last date of admission to the health institution, the status of applying to the health institution due to infection recently ()yes ()no, presence of pressure sores in the patient ()no, ()stage 1, ()stage 2, ()stage 3, ()stage 4, the patient's diet ()oral ()enteral ()parenteral, presence of constipation-diarrhea in the patient ()yes ()no, presence of incontinence in the patient ()yes () no, dementia status ()yes ()no, risk of falling ()yes ()no

    It is the 16th week after the completion of the training, and the final evaluation will be made for the patients.

Secondary Outcomes (6)

  • Caregiver Response Rating Scale

    The caregivers will be evaluated by using the Caregiver Response Evaluation Scale within the first week before the individuals who care for stroke home care patients are given training.

  • Caregiver Response Rating Scale

    After the training based on the Precede-Proceed Model is given to the caregivers of stroke home care patients, the caregivers will be evaluated using the Caregiver Response Evaluation Scale at the end of the 8th week.

  • Caregiver Response Rating Scale

    After the training based on the Precede-Proceed Model is given to the caregivers of stroke home care patients, the caregivers will be evaluated using the Caregiver Response Evaluation Scale at the end of the 16th week.

  • Multidimensional Scale of Perceived Social Support

    Individuals who care for stroke home care patients will be evaluated by using the Multidimensional Scale of Perceived Social Support in the first week without training.

  • Multidimensional Scale of Perceived Social Support

    After the training based on the Precede-Proceed Model is given to the caregivers of stroke home care patients, the caregivers will be evaluated using the Multidimensional Scale of Perceived Social Support at the end of the 8th week.

  • +1 more secondary outcomes

Study Arms (2)

stroke home care patient

NO INTERVENTION

Before applying the education program based on the Precede-Proceed Model to 70 individuals who care for stroke home care patients, the evaluation of the patients will be made with home visits. After the training is given to the caregivers, the first evaluation will be made at the 8th week in order to determine the change in patient results after the training is completed. In the 16th week after the completion of the training, a final evaluation will be made with home visits to determine the change in patient results.

Individuals caring for stroke home care patients

EXPERIMENTAL

Before the training program based on the Precede-Proceed Model is applied to the 70 individuals who care for stroke home care patients, the evaluation of the caregivers will be made in the hospital meeting room. After the training is given to the caregivers, the first evaluation will be made at the 8th week in order to determine the changes in their caregiving reactions and social support perceptions after the training is completed. In the 16th week after the completion of the training, a final evaluation will be made in the hospital meeting room in order to determine the changes in caregiver reactions and social support perceptions.

Behavioral: Educational intervention based on the Precede-Proceed Model for individuals caring for stroke home care patients

Interventions

Home visits will be made to 70 stroke patients identified during the implementation phase of the research, and training based on the Precede-Proceed model will be given to 70 individuals who care for these patients in the meeting room of the hospital where the research will be conducted. In the research, pre-education evaluation will be collected at the hospital before the training for the caregivers and home visits for the patients. In the second stage, the training program planned for the caregivers will be implemented in the meeting room of the hospital. After the training program reaches all of the caregivers in the determined number, the first evaluation will be made for the caregivers and the patient in the 8th week after the training is over. The third stage is the 16th week after the completion of the training, and the final evaluation will be made for the patients and caregivers.

Individuals caring for stroke home care patients

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals who care for semi-dependent or fully dependent stroke home care patients who agree to participate in the study,
  • No communication problems,
  • Do not have any psychiatric disorders that will reduce the ability to comprehend and understand,
  • Caregivers over the age of 18.
  • Semi-dependent or fully dependent stroke home care patients,
  • Adult patients,
  • Patients whose legal guardians or who have agreed to participate in the research themselves,

You may not qualify if:

  • The refusal of caregivers or patients to participate in the study,
  • The caregiver ceases to provide care or the patient dies during the research,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hatay Mustafa Kemal University

Hatay, Turkey (Türkiye)

Location

Related Publications (3)

  • Akcoban S, Eskimez Z. Homecare patients' quality of life and the burden of family caregivers: a descriptive cross-sectional study. Home Health Care Serv Q. 2023 Jul-Sep;42(3):216-229. doi: 10.1080/01621424.2023.2177224. Epub 2023 Feb 12.

    PMID: 36774648BACKGROUND
  • Langhorne P, Ramachandra S; Stroke Unit Trialists' Collaboration. Organised inpatient (stroke unit) care for stroke: network meta-analysis. Cochrane Database Syst Rev. 2020 Apr 23;4(4):CD000197. doi: 10.1002/14651858.CD000197.pub4.

    PMID: 32324916BACKGROUND
  • Sezgin D, Esin MN. Effects of a PRECEDE-PROCEED model based ergonomic risk management programme to reduce musculoskeletal symptoms of ICU nurses. Intensive Crit Care Nurs. 2018 Aug;47:89-97. doi: 10.1016/j.iccn.2018.02.007. Epub 2018 Mar 31.

    PMID: 29609839BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • SÜMEYYE AKÇOBAN

    Mustafa Kemal University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: two groups
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

May 22, 2023

First Posted

June 13, 2023

Study Start

July 13, 2023

Primary Completion

July 18, 2023

Study Completion

December 18, 2023

Last Updated

December 11, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations