Training Given to Caregivers of Stroke Home Care Patients.

December 6, 2024 updated by: Sumeyye Akcoban, Mustafa Kemal University

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The research will be carried out face-to-face with 70 stroke patients who receive health care from the home health services unit of a State Hospital and 70 individuals who care for these patients between July 2023 and December 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey
      • Hatay, Turkey
        • Hatay Mustafa Kemal University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: stroke home care patient
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.
Experimental: Individuals caring for stroke home care patients
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Patient Evaluation Form
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.
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
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.
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
Time Frame: It is the 16th week after the completion of the training, and the final evaluation will be made for the patients.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Caregiver Response Rating Scale
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.
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.
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
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.
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.
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
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.
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.
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
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.
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.
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
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.
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.
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.
Multidimensional Scale of 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.
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mustafa Kemal University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: SÜMEYYE AKÇOBAN, Mustafa Kemal University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 13, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 18, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 18, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 22, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 13, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 11, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 6, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HMKU-KMY-SA-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stroke

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

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings