Back to resultsVideo-Assisted Instruction in Type 2 Diabetes Patients
Primary Purpose
Education, Patient
Status
Active
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Video-assisted training
Sponsored by
About this trial
This is an interventional prevention trial for Education, Patient focused on measuring self-management, Type 2 diabetes mellitus, video-assisted instruction
Eligibility Criteria
Inclusion Criteria: 18-65 years Have no hearing or communication problems Self-injecting insulin Exclusion Criteria: Being a health care professionals Having chronic complications such as stroke, who had mental problems Pregnant Having visual-hearingand communication problems Having advanced retinopathy, nephropathy and neuropathy
Sites / Locations
- izmir Bakircay University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Video-assisted training group
Arm Description
The researcher will train the patients on insulin therapy and administration. The following program will be used in patient trainings. Training Program: Blended education methods such as lecture method, question and answer, video and demonstration were used as training methods. First of all, the researcher verbally will explaine how to administer the injection with an insulin pen. After the verbal training, he will show a video recording of insulin therapy and administration. Then, the author will show the administration of insulin injection on the model as practice and repeated explanations. The patients will be practiced the skill on the model.
Outcomes
Primary Outcome Measures
Insulin Treatment Self-Management Scale 1 (Questionnaire)
Patients' self-injection practices will be evaluated using the observation form before and after the training. Developed by the researchers based on the literature, the form consists of 18 items and includes administration of insulin injection. The data is recorded on the observation form while the patient is self-injecting insulin. Evaluation included marking on the form whether or not the patient performed each step by writing "done" or "not done" on the form. The patients receive one(1) point for each step they performed and zero (0) points for lack of performance in any given step. The maximum score that can be obtained for the observation form is 18, and the minimum score that can be obtained is zero (0).
Insulin Treatment Self-Management Scale 2 (Questionnaire)
Patients' self-injection practices will be evaluated using the observation form before and after the training. Developed by the researchers based on the literature, the form consists of 18 items and includes administration of insulin injection. The data is recorded on the observation form while the patient is self-injecting insulin. Evaluation included marking on the form whether or not the patient performed each step by writing "done" or "not done" on the form. The patients receive one(1) point for each step they performed and zero (0) points for lack of performance in any given step. The maximum score that can be obtained for the observation form is 18, and the minimum score that can be obtained is zero (0).
Insulin Administration Observation Form 1
The scale was developed by Okuroğlu et al. in 2019. The scale identifies knowledge and skill levels of individuals diagnosed with diabetes and their attitudes towards insulin therapy. The 5-point Likert type scale consists of 32 items. The lowest score obtained from the scale is 32, and the highest score is 160. The scale consists of three (3) sub-dimensions: behavioural, cognitive and affective. The lowest score that can be obtained from the behavioural sub-dimension with 17 items is 17, and the highest score is 85. The lowest score that can be obtained from the cognitive sub-dimension, with seven (7) items, is 7, and the highest score is 35. The lowest score that can be obtained from the affective sub-dimension with eight (8) items is 8, and the highest score is 40. A high score from the scale indicates that patients have high self-management. The Cronbach alpha value of the scale is 0.91.25
Insulin Administration Observation Form 2
The scale was developed by Okuroğlu et al. in 2019. The scale identifies knowledge and skill levels of individuals diagnosed with diabetes and their attitudes towards insulin therapy. The 5-point Likert type scale consists of 32 items. The lowest score obtained from the scale is 32, and the highest score is 160. The scale consists of three (3) sub-dimensions: behavioural, cognitive and affective. The lowest score that can be obtained from the behavioural sub-dimension with 17 items is 17, and the highest score is 85. The lowest score that can be obtained from the cognitive sub-dimension, with seven (7) items, is 7, and the highest score is 35. The lowest score that can be obtained from the affective sub-dimension with eight (8) items is 8, and the highest score is 40. A high score from the scale indicates that patients have high self-management. The Cronbach alpha value of the scale is 0.91.25
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05926388
Brief Title
Video-Assisted Instruction in Type 2 Diabetes Patients
Official Title
The Effect of Video-Assisted Instruction in Type 2 Diabetes Patients' Insulin Self-Management and Insulin Administration Skills
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 10, 2022 (Actual)
Primary Completion Date
May 10, 2022 (Actual)
Study Completion Date
August 10, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Izmir Bakircay 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
Objective: To examine the effect of video-assisted instruction on Type 2 diabetes patients' insulin treatment self-management and insulin administration skills. The research will be conducted as a single group pre-test post-test quasi-experimental study. The sample of the study will be consisted of 50 patients with Type 2 Diabetes. Inclusion criteria: patients between the ages of 18-65, without hearing or communication problems, who self-injecting insulin. Before the training, the patients will be self-injected a dose of insulin. After giving verbal training, the patients will watch a video recording of insulin treatment and administration. The author will be evaluated the patients' insulin treatment self-management and insulin administration skills after the training.
Detailed Description
The research will be conducted as a single group pre-test post-test quasi-experimental study. The sample of the study will be consisted of 50 patients with Type 2 Diabetes. Inclusion criteria: patients between the ages of 18-65, without hearing or communication problems, who self-injecting insulin. Before the training, the patients will be self-injected a dose of insulin. After giving verbal training, the patients will watch a video recording of insulin treatment and administration. The author will be evaluated the patients' insulin treatment self-management and insulin administration skills after the training.
.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Education, Patient
Keywords
self-management, Type 2 diabetes mellitus, video-assisted instruction
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Video-assisted training group
Arm Type
Experimental
Arm Description
The researcher will train the patients on insulin therapy and administration. The following program will be used in patient trainings.
Training Program: Blended education methods such as lecture method, question and answer, video and demonstration were used as training methods. First of all, the researcher verbally will explaine how to administer the injection with an insulin pen. After the verbal training, he will show a video recording of insulin therapy and administration. Then, the author will show the administration of insulin injection on the model as practice and repeated explanations. The patients will be practiced the skill on the model.
Intervention Type
Other
Intervention Name(s)
Video-assisted training
Intervention Description
Patients will be given training on insulin therapy and management using lecture, question-answer, video and demonstration methods.
Primary Outcome Measure Information:
Title
Insulin Treatment Self-Management Scale 1 (Questionnaire)
Description
Patients' self-injection practices will be evaluated using the observation form before and after the training. Developed by the researchers based on the literature, the form consists of 18 items and includes administration of insulin injection. The data is recorded on the observation form while the patient is self-injecting insulin. Evaluation included marking on the form whether or not the patient performed each step by writing "done" or "not done" on the form. The patients receive one(1) point for each step they performed and zero (0) points for lack of performance in any given step. The maximum score that can be obtained for the observation form is 18, and the minimum score that can be obtained is zero (0).
Time Frame
Seven days after the training
Title
Insulin Treatment Self-Management Scale 2 (Questionnaire)
Description
Patients' self-injection practices will be evaluated using the observation form before and after the training. Developed by the researchers based on the literature, the form consists of 18 items and includes administration of insulin injection. The data is recorded on the observation form while the patient is self-injecting insulin. Evaluation included marking on the form whether or not the patient performed each step by writing "done" or "not done" on the form. The patients receive one(1) point for each step they performed and zero (0) points for lack of performance in any given step. The maximum score that can be obtained for the observation form is 18, and the minimum score that can be obtained is zero (0).
Time Frame
Five weeks after the training
Title
Insulin Administration Observation Form 1
Description
The scale was developed by Okuroğlu et al. in 2019. The scale identifies knowledge and skill levels of individuals diagnosed with diabetes and their attitudes towards insulin therapy. The 5-point Likert type scale consists of 32 items. The lowest score obtained from the scale is 32, and the highest score is 160. The scale consists of three (3) sub-dimensions: behavioural, cognitive and affective. The lowest score that can be obtained from the behavioural sub-dimension with 17 items is 17, and the highest score is 85. The lowest score that can be obtained from the cognitive sub-dimension, with seven (7) items, is 7, and the highest score is 35. The lowest score that can be obtained from the affective sub-dimension with eight (8) items is 8, and the highest score is 40. A high score from the scale indicates that patients have high self-management. The Cronbach alpha value of the scale is 0.91.25
Time Frame
Seven days after the training
Title
Insulin Administration Observation Form 2
Description
The scale was developed by Okuroğlu et al. in 2019. The scale identifies knowledge and skill levels of individuals diagnosed with diabetes and their attitudes towards insulin therapy. The 5-point Likert type scale consists of 32 items. The lowest score obtained from the scale is 32, and the highest score is 160. The scale consists of three (3) sub-dimensions: behavioural, cognitive and affective. The lowest score that can be obtained from the behavioural sub-dimension with 17 items is 17, and the highest score is 85. The lowest score that can be obtained from the cognitive sub-dimension, with seven (7) items, is 7, and the highest score is 35. The lowest score that can be obtained from the affective sub-dimension with eight (8) items is 8, and the highest score is 40. A high score from the scale indicates that patients have high self-management. The Cronbach alpha value of the scale is 0.91.25
Time Frame
Five weeks after the training
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18-65 years
Have no hearing or communication problems
Self-injecting insulin
Exclusion Criteria:
Being a health care professionals
Having chronic complications such as stroke, who had mental problems
Pregnant
Having visual-hearingand communication problems
Having advanced retinopathy, nephropathy and neuropathy
Facility Information:
Facility Name
izmir Bakircay University
City
İzmir
State/Province
Menemen
ZIP/Postal Code
35160
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Video-Assisted Instruction in Type 2 Diabetes Patients
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