Ignite Creation Date:
2024-05-06 @ 5:03 PM
Last Modification Date:
2024-10-26 @ 2:21 PM
Study NCT ID:
NCT05174975
Status:
COMPLETED
Last Update Posted:
2023-11-24
First Post:
2021-11-16
Brief Title:
Effectiveness of App-based Positive Psychological Intervention on Patients Newly Diagnosed With Type 2 Diabetes
Sponsor:
Tri-Service General Hospital
Organization:
Tri-Service General Hospital
Study Overview
Official Title:
Tri-Service General Hospital Department of Internal Medicine
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this experimental study is to explore the effectiveness of app-based positive psychology intervention PPI on patients newly diagnosed with type 2 diabetes T2DM
Detailed Description:
Positive psychological constructs PPCs such as optimism gratitude self-efficacy and resilience have been considered to positively impact adherence and self-care behaviour of patients with type 2 diabetes T2DM Moreover diabetes self-care behaviours would be consistently improved as the PPCs have strengthened Based on systematic reviews the positive psychological intervention has significantly improved positive emotions quality of life self-efficacy depression optimism gratitude and well-being of patients with T2DM The strengthen of PPCs could be regarded as a strategy for improving type 2 diabetes self-management
Positive psychology intervention PPI emphasis enhancing PPCs via consciousness raising and enhancing personal strengths With the systemic practice of PPI it develops individual positive cognition and emotions A previous Internet-based intervention study found that people have been taught positive emotional skills shown a significantly lower depression level than those having the daily emotional diary Additionally a one-group pre-post test study found that both optimism and gratitude have significantly increased after a 12-week phone-based PPI in patients with T2DM Another one-group pretest-posttest study demonstrated that optimism and well-being had significantly increased after a 12-week PPI Furthermore optimism gratitude frustrated depressive and distress diabetes self-care and health behaviours adherence have obvious improved A recent study demonstrated that self-care behaviour and diet behaviour had significantly improved after a 16-week phone-based psychological-motivational interviewing intervention among the patients with Type 2 diabetes T2DM with 8 years duration of diabetes Although previous studies have demonstrated the effectiveness of PPI on PPCs only few studies investigate the impact on patients newly diagnosed with T2DM Thus the aim of this study is to explore the effectiveness of app-based PPI on patients newly diagnosed with T2DM
Patients newly diagnosed with T2DM of an endocrinology clinic in a medical center in northern Taiwan are assigned to the experimental group n57 while patients at an endocrinology clinic in southern Taiwan are assigned to the control group n113 Experimental group will have a 3-month App-based intervention while the control group only have a diabetes-related health education by certificated diabetes educators Outcome variables will be collected from medical records and self-reported questionnaires A Generalized Estimation Equation GEE is used to compare the changing amount of outcome variables from baseline to week at the end of intervention to 3 months and to 9 months post-intervention between a control group and experimental group A p-value 05 is considered statistically significant
Positive psychology intervention PPI emphasis enhancing PPCs via consciousness raising and enhancing personal strengths With the systemic practice of PPI it develops individual positive cognition and emotions A previous Internet-based intervention study found that people have been taught positive emotional skills shown a significantly lower depression level than those having the daily emotional diary Additionally a one-group pre-post test study found that both optimism and gratitude have significantly increased after a 12-week phone-based PPI in patients with T2DM Another one-group pretest-posttest study demonstrated that optimism and well-being had significantly increased after a 12-week PPI Furthermore optimism gratitude frustrated depressive and distress diabetes self-care and health behaviours adherence have obvious improved A recent study demonstrated that self-care behaviour and diet behaviour had significantly improved after a 16-week phone-based psychological-motivational interviewing intervention among the patients with Type 2 diabetes T2DM with 8 years duration of diabetes Although previous studies have demonstrated the effectiveness of PPI on PPCs only few studies investigate the impact on patients newly diagnosed with T2DM Thus the aim of this study is to explore the effectiveness of app-based PPI on patients newly diagnosed with T2DM
Patients newly diagnosed with T2DM of an endocrinology clinic in a medical center in northern Taiwan are assigned to the experimental group n57 while patients at an endocrinology clinic in southern Taiwan are assigned to the control group n113 Experimental group will have a 3-month App-based intervention while the control group only have a diabetes-related health education by certificated diabetes educators Outcome variables will be collected from medical records and self-reported questionnaires A Generalized Estimation Equation GEE is used to compare the changing amount of outcome variables from baseline to week at the end of intervention to 3 months and to 9 months post-intervention between a control group and experimental group A p-value 05 is considered statistically significant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None