Effectiveness of App-based Positive Psychological Intervention on Patients Newly Diagnosed With Type 2 Diabetes

Study Overview
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Brief Summary
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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
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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 (n=57), while patients at an endocrinology clinic in southern Taiwan are assigned to the control group (n=113). 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.

Official Title
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Tri-Service General Hospital, Department of Internal Medicine

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Behavioral: App-based Positive Psychological Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: newly diagnosed with T2DM less than 6 months aged 20 to 64 controlling diabetes through oral medication or insulin injection able to use Android phone Exclusion Criteria: unable to communicate with language or having mental illness

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants are assigned to two groups in parallel for the duration of the study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: App-based Positive Psychological Intervention group<br>The intervention will be conducted on the app, including 2-week PPI, diabetes-related health education, physical records, and online consultation. | Behavioral: App-based Positive Psychological Intervention<br>* The PPI has included a 12-week PPI lessons. Each lesson has separated into 3 parts: introduction, activity, and feedback. Diabetes-related health education will include the basic knowledge of diabetes, diet, and exercise related videos. Physical records include record of daily blood sugar, blood pressure, HbA1c, diet, and exercise. In terms of dietary records, the amount of carbohydrates of each food will be calculate automatically after documented. Exercise records documents the burn of calories of each exercise (per 30 minutes). Both unit of dietary and exercise are based on Health Promotion Administration's criteria in Taiwan. Moreover, participants are available to have one-on-one instant online consultation with their diabetes educators via App.<br>|
| No Intervention: control group<br>usual care which will educated by certificated educators in terms of self-management | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Quality of life | A 15-item Quality of Life Scale will be used to measure quality of life. Each item is rated from 0 (Never) to 4(Always), with higher scores indicating a higher quality of life. | At baseline and 1 week, 3 months and 9 months after the interventiont | 
| Change in Self-care behaviour | A 17-item Diabetes Self-care Behaviour Scale-Chinese version will be used to measure. Each item is rates from 0 (never) to 4 (always). The higher score indicates a greater execution in self-care behaviours. | At baseline and 1 week, 3 months and 9 months after the intervention | 
| Change in Glycosylated hemoglobin(HbA1c) levels | Collect from medical records | At baseline and 1 week, 3 months and 9 months after the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Diabetes Distress | A 8-item short form of Problem Areas in Diabetes scale in Chinese version will be used to measure. Each items is rated from 0 (not a problem) to 4 (very serious problem). The higher score indicates a greater level of diabetes distress. | At baseline and 1 week, 3 months and 9 months after the intervention | 
| Change in Optimism | A 6-item Life Orientation Test-Revised will be used to measure. Each item is rated from 0 as strongly disagree to 4 as strongly agree. The higher scores indicates higher dispositional level of optimism. | At baseline and 1 week, 3 months and 9 months after the intervention | 
| Change in Gratitude | A 6-item Gratitude Questionnaire will be used to measure. Each item is rated from 1 (strongly disagree) to 7 (strongly agree). The higher score indicates higher gratitude disposition. | At baseline and 1 week, 3 months and 9 months after the intervention | 
| Change in Diabetes Self-efficacy | A 14-item Diabetes Self-efficacy scale will be used to measure. Each item is rated from 0 as Extremely unconfident to 4 as 80% to 100% confident. The higher score indicates the better self-efficacy. | At baseline and 1 week, 3 months and 9 months after the interventiont | 
| Change in Diabetic Positive Characteristics | A 20-item Diabetic Positive Characteristic Scale will be used to measure. Each item is rated from 1 as strongly disagree to 5 as strongly agree. The overall score is 100 points, with higher scores indicating greater likelihood of positive characteristics disposition. | At baseline and 1 week, 3 months and 9 months after the intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes mellitus, self-care behaviors, quality of lofe