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Training Given to Caregivers of Stroke Home Care Patients.

Primary Purpose

Stroke

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Educational intervention based on the Precede-Proceed Model for individuals caring for stroke home care patients
Sponsored by
Mustafa Kemal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stroke focused on measuring Stroke, Home Care Services, Caregivers, Social Support, Patient-Relevant Outcome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hatay Mustafa Kemal UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

stroke home care patient

Individuals caring for stroke home care patients

Arm Description

Before applying the education program based on the Precede-Proceed Model to 50 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.

Before the training program based on the Precede-Proceed Model is applied to the 50 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.

Outcomes

Primary Outcome Measures

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
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
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

Secondary Outcome Measures

Caregiver Response Rating Scale
The Caregiver Response Evaluation Scale is used in the primary care of patients with physical and mental disorders to provide self-evaluation of caregivers. The scale consists of 24 items and 5 sub-dimensions. The scale has a 5-point Likert type scoring. Positive items in the scale; 7, 13, 3, 15, 19 while negative items are 1, 2, 4, 5, 6, 8, 9, 10, 11, 12, 14, 16, 17, 18, 20, 21, 22, 23, 24' type. While scoring the positive items, the value of 1 is converted to 5, and the value of 5 is converted to 1 in the scoring. In the scoring (total score 24-120), the scores of the answers given to the statements in each sub-dimension are summed, Interruption of daily life (5-25), financial distress (3-15), lack of family support (5-25), and health problems (4- High scores in the 20) sub-dimensions indicate that the caregivers are more distressed, and a high score in the Self-worth (7-35) sub-dimension indicates that the caregivers are in good condition.
Caregiver Response Rating Scale
The Caregiver Response Evaluation Scale is used in the primary care of patients with physical and mental disorders to provide self-evaluation of caregivers. The scale consists of 24 items and 5 sub-dimensions. The scale has a 5-point Likert type scoring. Positive items in the scale; 7, 13, 3, 15, 19 while negative items are 1, 2, 4, 5, 6, 8, 9, 10, 11, 12, 14, 16, 17, 18, 20, 21, 22, 23, 24' type. While scoring the positive items, the value of 1 is converted to 5, and the value of 5 is converted to 1 in the scoring. In the scoring (total score 24-120), the scores of the answers given to the statements in each sub-dimension are summed, Interruption of daily life (5-25), financial distress (3-15), lack of family support (5-25), and health problems (4- High scores in the 20) sub-dimensions indicate that the caregivers are more distressed, and a high score in the Self-worth (7-35) sub-dimension indicates that the caregivers are in good condition.
Caregiver Response Rating Scale
The Caregiver Response Evaluation Scale is used in the primary care of patients with physical and mental disorders to provide self-evaluation of caregivers. The scale consists of 24 items and 5 sub-dimensions. The scale has a 5-point Likert type scoring. Positive items in the scale; 7, 13, 3, 15, 19 while negative items are 1, 2, 4, 5, 6, 8, 9, 10, 11, 12, 14, 16, 17, 18, 20, 21, 22, 23, 24' type. While scoring the positive items, the value of 1 is converted to 5, and the value of 5 is converted to 1 in the scoring. In the scoring (total score 24-120), the scores of the answers given to the statements in each sub-dimension are summed, Interruption of daily life (5-25), financial distress (3-15), lack of family support (5-25), and health problems (4- High scores in the 20) sub-dimensions indicate that the caregivers are more distressed, and a high score in the Self-worth (7-35) sub-dimension indicates that the caregivers are in good condition.
Multidimensional Scale of Perceived Social Support
It is a scale to determine the social support elements perceived by individuals. The scale, which consists of 12 items in total, is a 7-point Likert-type scale (1-7) arranged as "definitely no 1 2 3 4 5 6 7 absolutely yes". It has three subscales. Items 3.4.8.11 in the scale measure support from family, items 6.7.9.12 measure support from friends and items 1.2.5.10 measure support from a special person. The lowest score that can be obtained from the subscales is 4 and the highest score is 28. The lowest score to be obtained from all of them is 12 and the highest score is 84. A high score indicates high perceived social support.
Multidimensional Scale of Perceived Social Support
It is a scale to determine the social support elements perceived by individuals. The scale, which consists of 12 items in total, is a 7-point Likert-type scale (1-7) arranged as "definitely no 1 2 3 4 5 6 7 absolutely yes". It has three subscales. Items 3.4.8.11 in the scale measure support from family, items 6.7.9.12 measure support from friends and items 1.2.5.10 measure support from a special person. The lowest score that can be obtained from the subscales is 4 and the highest score is 28. The lowest score to be obtained from all of them is 12 and the highest score is 84. A high score indicates high perceived social support.
Multidimensional Scale of Perceived Social Support
It is a scale to determine the social support elements perceived by individuals. The scale, which consists of 12 items in total, is a 7-point Likert-type scale (1-7) arranged as "definitely no 1 2 3 4 5 6 7 absolutely yes". It has three subscales. Items 3.4.8.11 in the scale measure support from family, items 6.7.9.12 measure support from friends and items 1.2.5.10 measure support from a special person. The lowest score that can be obtained from the subscales is 4 and the highest score is 28. The lowest score to be obtained from all of them is 12 and the highest score is 84. A high score indicates high perceived social support.

Full Information

First Posted
May 22, 2023
Last Updated
August 9, 2023
Sponsor
Mustafa Kemal University
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1. Study Identification

Unique Protocol Identification Number
NCT05901909
Brief Title
Training Given to Caregivers of Stroke Home Care Patients.
Official Title
The Effect of the Education Program Based on the Precede-Proceed Model to the Caregivers of Stroke Home Care Patients on Care Giving Response, Perceived Social Support Level, and Patient Outcomes.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 13, 2023 (Actual)
Primary Completion Date
July 31, 2023 (Actual)
Study Completion Date
November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mustafa Kemal University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The research will be carried out face-to-face with 50 stroke patients who receive health care from the home health services unit of a State Hospital and 50 individuals who care for these patients between 01 July 2023 and 01 November 2023. This study is a single-sample study with its own control group. During the implementation phase of the research, home visits will be made to the patients and training based on the Precede-Proceed model will be given to the individuals who care for the patients in the meeting room of the hospital where the research will be conducted. The collection of research data will take place in three stages. 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. In the study, data will be collected using the individual caregiver personal information form, the caregiver response rating scale and the multidimensional perceived social support scale, and the patient personal information form for the patients. Statistical significance level will be accepted as p<0.05.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Home Care Services, Caregivers, Social Support, Patient-Relevant Outcome

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
two groups
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
stroke home care patient
Arm Type
No Intervention
Arm Description
Before applying the education program based on the Precede-Proceed Model to 50 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.
Arm Title
Individuals caring for stroke home care patients
Arm Type
Experimental
Arm Description
Before the training program based on the Precede-Proceed Model is applied to the 50 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.
Intervention Type
Behavioral
Intervention Name(s)
Educational intervention based on the Precede-Proceed Model for individuals caring for stroke home care patients
Intervention Description
Home visits will be made to 50 stroke patients identified during the implementation phase of the research, and training based on the Precede-Proceed model will be given to 50 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.
Primary Outcome Measure Information:
Title
Patient Evaluation Form
Description
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
Time Frame
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.
Title
Patient Evaluation Form
Description
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
Time Frame
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.
Title
Patient Evaluation Form
Description
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
Time Frame
It is the 16th week after the completion of the training, and the final evaluation will be made for the patients.
Secondary Outcome Measure Information:
Title
Caregiver Response Rating Scale
Description
The Caregiver Response Evaluation Scale is used in the primary care of patients with physical and mental disorders to provide self-evaluation of caregivers. The scale consists of 24 items and 5 sub-dimensions. The scale has a 5-point Likert type scoring. Positive items in the scale; 7, 13, 3, 15, 19 while negative items are 1, 2, 4, 5, 6, 8, 9, 10, 11, 12, 14, 16, 17, 18, 20, 21, 22, 23, 24' type. While scoring the positive items, the value of 1 is converted to 5, and the value of 5 is converted to 1 in the scoring. In the scoring (total score 24-120), the scores of the answers given to the statements in each sub-dimension are summed, Interruption of daily life (5-25), financial distress (3-15), lack of family support (5-25), and health problems (4- High scores in the 20) sub-dimensions indicate that the caregivers are more distressed, and a high score in the Self-worth (7-35) sub-dimension indicates that the caregivers are in good condition.
Time Frame
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.
Title
Caregiver Response Rating Scale
Description
The Caregiver Response Evaluation Scale is used in the primary care of patients with physical and mental disorders to provide self-evaluation of caregivers. The scale consists of 24 items and 5 sub-dimensions. The scale has a 5-point Likert type scoring. Positive items in the scale; 7, 13, 3, 15, 19 while negative items are 1, 2, 4, 5, 6, 8, 9, 10, 11, 12, 14, 16, 17, 18, 20, 21, 22, 23, 24' type. While scoring the positive items, the value of 1 is converted to 5, and the value of 5 is converted to 1 in the scoring. In the scoring (total score 24-120), the scores of the answers given to the statements in each sub-dimension are summed, Interruption of daily life (5-25), financial distress (3-15), lack of family support (5-25), and health problems (4- High scores in the 20) sub-dimensions indicate that the caregivers are more distressed, and a high score in the Self-worth (7-35) sub-dimension indicates that the caregivers are in good condition.
Time Frame
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.
Title
Caregiver Response Rating Scale
Description
The Caregiver Response Evaluation Scale is used in the primary care of patients with physical and mental disorders to provide self-evaluation of caregivers. The scale consists of 24 items and 5 sub-dimensions. The scale has a 5-point Likert type scoring. Positive items in the scale; 7, 13, 3, 15, 19 while negative items are 1, 2, 4, 5, 6, 8, 9, 10, 11, 12, 14, 16, 17, 18, 20, 21, 22, 23, 24' type. While scoring the positive items, the value of 1 is converted to 5, and the value of 5 is converted to 1 in the scoring. In the scoring (total score 24-120), the scores of the answers given to the statements in each sub-dimension are summed, Interruption of daily life (5-25), financial distress (3-15), lack of family support (5-25), and health problems (4- High scores in the 20) sub-dimensions indicate that the caregivers are more distressed, and a high score in the Self-worth (7-35) sub-dimension indicates that the caregivers are in good condition.
Time Frame
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.
Title
Multidimensional Scale of Perceived Social Support
Description
It is a scale to determine the social support elements perceived by individuals. The scale, which consists of 12 items in total, is a 7-point Likert-type scale (1-7) arranged as "definitely no 1 2 3 4 5 6 7 absolutely yes". It has three subscales. Items 3.4.8.11 in the scale measure support from family, items 6.7.9.12 measure support from friends and items 1.2.5.10 measure support from a special person. The lowest score that can be obtained from the subscales is 4 and the highest score is 28. The lowest score to be obtained from all of them is 12 and the highest score is 84. A high score indicates high perceived social support.
Time Frame
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.
Title
Multidimensional Scale of Perceived Social Support
Description
It is a scale to determine the social support elements perceived by individuals. The scale, which consists of 12 items in total, is a 7-point Likert-type scale (1-7) arranged as "definitely no 1 2 3 4 5 6 7 absolutely yes". It has three subscales. Items 3.4.8.11 in the scale measure support from family, items 6.7.9.12 measure support from friends and items 1.2.5.10 measure support from a special person. The lowest score that can be obtained from the subscales is 4 and the highest score is 28. The lowest score to be obtained from all of them is 12 and the highest score is 84. A high score indicates high perceived social support.
Time Frame
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.
Title
Multidimensional Scale of Perceived Social Support
Description
It is a scale to determine the social support elements perceived by individuals. The scale, which consists of 12 items in total, is a 7-point Likert-type scale (1-7) arranged as "definitely no 1 2 3 4 5 6 7 absolutely yes". It has three subscales. Items 3.4.8.11 in the scale measure support from family, items 6.7.9.12 measure support from friends and items 1.2.5.10 measure support from a special person. The lowest score that can be obtained from the subscales is 4 and the highest score is 28. The lowest score to be obtained from all of them is 12 and the highest score is 84. A high score indicates high perceived social support.
Time Frame
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 16th week.

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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, Exclusion Criteria: The refusal of caregivers or patients to participate in the study, The caregiver ceases to provide care or the patient dies during the research,
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
SÜMEYYE AKÇOBAN
Phone
+905434810553
Email
sumeyyea2016@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
BETÜL TOSUN
Phone
+905053652121
Email
tosunbetul@gmail.com
Facility Information:
Facility Name
Hatay Mustafa Kemal University
City
Hatay
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sumeyye Akcoban
Phone
05434810553
Email
sumeyyea2016@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36774648
Citation
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.
Results Reference
background
PubMed Identifier
32324916
Citation
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.
Results Reference
background
PubMed Identifier
29609839
Citation
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.
Results Reference
background

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Training Given to Caregivers of Stroke Home Care Patients.

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