Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06538168
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-31
Brief Title:
Effectiveness of a Digital Health Education on Self-Foot Care and Quality of Life Among Patients With Diabetes
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effect of a Comprehensive Digital Health Education on Self-Foot Care and Quality of Life Among Patients With Diabetes
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Diabetes is a significant global health concern affecting over half a billion people and leading to severe complications like diabetic foot ulcers DFUs The increasing incidence of DFUs highlights the need for ongoing research and effective prevention strategies A major challenge in managing DFUs is the inadequate preparation of healthcare professionals HCPs in delivering comprehensive diabetes self-management education DSME Enhancing the education and training of HCPs is essential to improve diabetes management and reduce DFUs
Studies show that patients knowledge and self-care practices vary widely with common foot-care activities including washing drying applying moisturizer and routine nail care Improving these self-care practices is crucial for early recognition and management of DFUs to reduce the risk of amputations
Health promotion models such as the Self-Efficacy Theory and Health Belief Model have shown promise in informing foot care interventions but further research is needed to determine the most effective strategies Previous research has several limitations including selection bias lack of consensus on outcome measures and moderate risk of bias in some studies
The proposed study will use an experimental design with a nonequivalent control group to assess the effectiveness of DSME in reducing non-ulcerated diabetic foot incidents Data will be collected using the Diabetes Self-Care Activities Foot Care Questionnaire and analyzed with statistical tests Ethical guidelines will be strictly followed ensuring participant confidentiality and voluntary participation
Overall this research aims to address gaps in diabetes education and promote behavioral changes to improve diabetes care and reduce DFUs Continuous training and education for HCPs are vital for enhancing their competence in managing DFUs and improving patient outcomes
Studies show that patients knowledge and self-care practices vary widely with common foot-care activities including washing drying applying moisturizer and routine nail care Improving these self-care practices is crucial for early recognition and management of DFUs to reduce the risk of amputations
Health promotion models such as the Self-Efficacy Theory and Health Belief Model have shown promise in informing foot care interventions but further research is needed to determine the most effective strategies Previous research has several limitations including selection bias lack of consensus on outcome measures and moderate risk of bias in some studies
The proposed study will use an experimental design with a nonequivalent control group to assess the effectiveness of DSME in reducing non-ulcerated diabetic foot incidents Data will be collected using the Diabetes Self-Care Activities Foot Care Questionnaire and analyzed with statistical tests Ethical guidelines will be strictly followed ensuring participant confidentiality and voluntary participation
Overall this research aims to address gaps in diabetes education and promote behavioral changes to improve diabetes care and reduce DFUs Continuous training and education for HCPs are vital for enhancing their competence in managing DFUs and improving patient outcomes
Detailed Description:
Diabetes is a major global health issue affecting over half a billion people worldwide leading to serious complications such as diabetic foot ulcers DFUs The increasing incidence of DFUs necessitates further research to manage and prevent these severe complications Healthcare professionals HCPs play a crucial role in addressing the rising incidence of diabetes and DFUs through capacity building and periodic education However many HCPs are inadequately prepared to deliver comprehensive diabetes self-management education DSME which is essential for preventing and treating DFUs
The World Health Organization WHO reports that approximately 422 million people with diabetes live in low- and middle-income countries with diabetes directly causing about 15 million deaths annually Over the past few decades there has been a consistent rise in both the incidence and prevalence of diabetes This condition significantly contributes to renal disease heart attacks strokes blindness and lower extremities amputation often resulting from infected foot ulcers About 15 to 25 of diabetic patients develop foot ulcers at some point Foot problems like ulcers infections and amputations are among the most significant complications of diabetes but these issues can often be avoided with consistent foot care
The study aims to understand how health promotion models have informed foot care interventions for older adults with diabetes A review of 2078 articles identified 31 studies that met eligibility criteria focusing on foot care interventions for older adults Most of these studies involved people with diabetes and used health promotion models such as the Self-Efficacy Theory and the Health Belief Model The interventions showed promising outcomes in improving foot care for older adults highlighting the need for further research to determine the most effective models and implementation strategies
Previous research has several limitations exclusion of relevant studies on intervention implementation lack of consensus on foot-related outcome measures selection bias due to convenience sampling techniques cross-sectional designs making causal inferences impossible moderate risk of bias in some studies restriction to studies conducted between 2004 and 2022 lack of randomized or controlled samples in some studies and immediate assessment of attitudes and skills post-training influencing health promotion models
This research addresses the lack of diabetes education and the limited adoption of behavioral changes among the population which lead to challenges in diabetes care Effective education for healthcare professionals communities and patients is essential to improve diabetes management and reduce the risk of complications such as DFUs The objectives of the study are to understand the contexts where health promotion models have informed foot care interventions identify the health promotion models used in these interventions and document the effectiveness of theoretically informed health promotion interventions in improving foot care for older adults
Health promotion models like the Self-Efficacy Theory and the Health Belief Model have shown promising outcomes in improving foot care behaviors and knowledge The studies vary in intervention approaches delivery methods and outcome measurements emphasizing the need for further research to determine the most effective models and implementation strategies There is a strong correlation between high knowledge of foot care and good practice with varying levels of knowledge and engagement in foot-care activities like washing drying applying moisturizer and trimming nails
The study will assess the impact of DSME on non-ulcer diabetic foot incidents through a structured research design and statistical analysis A review of existing studies shows that appropriate foot care practices are essential for preventing complications like DFUs Common self-care practices include washing feet with lukewarm water drying thoroughly using moisturizing cream inspecting feet daily nail care and wearing suitable footwear Outcome measures in these studies included foot health outcomes knowledge of foot health foot care behaviors and self-efficacy The need for standardized outcome measures and further research on the effectiveness and cost-benefit of foot care interventions for older adults is highlighted
The study will use an experimental design with a nonequivalent control group Consecutive sampling will divide 230 participants into intervention and control groups The Diabetes Self-Care Activities Foot Care Questionnaire will be used as the research instrument Statistical analyses will include the Wilcoxon Signed Ranks Test and Mann-Whitney Test to compare the mean incidence of non-ulcerated diabetic foot incidents before and after the intervention
The research will adhere to ethical guidelines ensuring participant confidentiality voluntary participation and informed consent Participants will be assured of their right to withdraw from the study at any time without any penalties
Overall this research aims to enhance diabetes education and promote behavioral changes to improve diabetes care and reduce the incidence of DFUs Continuous training and education for HCPs are crucial for improving their competence in managing DFUs and achieving better patient outcomes
The World Health Organization WHO reports that approximately 422 million people with diabetes live in low- and middle-income countries with diabetes directly causing about 15 million deaths annually Over the past few decades there has been a consistent rise in both the incidence and prevalence of diabetes This condition significantly contributes to renal disease heart attacks strokes blindness and lower extremities amputation often resulting from infected foot ulcers About 15 to 25 of diabetic patients develop foot ulcers at some point Foot problems like ulcers infections and amputations are among the most significant complications of diabetes but these issues can often be avoided with consistent foot care
The study aims to understand how health promotion models have informed foot care interventions for older adults with diabetes A review of 2078 articles identified 31 studies that met eligibility criteria focusing on foot care interventions for older adults Most of these studies involved people with diabetes and used health promotion models such as the Self-Efficacy Theory and the Health Belief Model The interventions showed promising outcomes in improving foot care for older adults highlighting the need for further research to determine the most effective models and implementation strategies
Previous research has several limitations exclusion of relevant studies on intervention implementation lack of consensus on foot-related outcome measures selection bias due to convenience sampling techniques cross-sectional designs making causal inferences impossible moderate risk of bias in some studies restriction to studies conducted between 2004 and 2022 lack of randomized or controlled samples in some studies and immediate assessment of attitudes and skills post-training influencing health promotion models
This research addresses the lack of diabetes education and the limited adoption of behavioral changes among the population which lead to challenges in diabetes care Effective education for healthcare professionals communities and patients is essential to improve diabetes management and reduce the risk of complications such as DFUs The objectives of the study are to understand the contexts where health promotion models have informed foot care interventions identify the health promotion models used in these interventions and document the effectiveness of theoretically informed health promotion interventions in improving foot care for older adults
Health promotion models like the Self-Efficacy Theory and the Health Belief Model have shown promising outcomes in improving foot care behaviors and knowledge The studies vary in intervention approaches delivery methods and outcome measurements emphasizing the need for further research to determine the most effective models and implementation strategies There is a strong correlation between high knowledge of foot care and good practice with varying levels of knowledge and engagement in foot-care activities like washing drying applying moisturizer and trimming nails
The study will assess the impact of DSME on non-ulcer diabetic foot incidents through a structured research design and statistical analysis A review of existing studies shows that appropriate foot care practices are essential for preventing complications like DFUs Common self-care practices include washing feet with lukewarm water drying thoroughly using moisturizing cream inspecting feet daily nail care and wearing suitable footwear Outcome measures in these studies included foot health outcomes knowledge of foot health foot care behaviors and self-efficacy The need for standardized outcome measures and further research on the effectiveness and cost-benefit of foot care interventions for older adults is highlighted
The study will use an experimental design with a nonequivalent control group Consecutive sampling will divide 230 participants into intervention and control groups The Diabetes Self-Care Activities Foot Care Questionnaire will be used as the research instrument Statistical analyses will include the Wilcoxon Signed Ranks Test and Mann-Whitney Test to compare the mean incidence of non-ulcerated diabetic foot incidents before and after the intervention
The research will adhere to ethical guidelines ensuring participant confidentiality voluntary participation and informed consent Participants will be assured of their right to withdraw from the study at any time without any penalties
Overall this research aims to enhance diabetes education and promote behavioral changes to improve diabetes care and reduce the incidence of DFUs Continuous training and education for HCPs are crucial for improving their competence in managing DFUs and achieving better patient outcomes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None