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Clinical Trials/NCT05174975
NCT05174975CompletedNot Applicable

Tri-Service General Hospital, Department of Internal Medicine

Tri-Service General Hospital1 site in 1 country100 target enrollmentStarted: October 20, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
100
Locations
1
Primary Endpoint
Change in Self-care behaviour

Study Overview

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 (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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
20 Years to 64 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

App-based Positive Psychological Intervention group

Experimental

The intervention will be conducted on the app, including 2-week PPI, diabetes-related health education, physical records, and online consultation.

Intervention: App-based Positive Psychological Intervention (Behavioral)

control group

No Intervention

usual care which will educated by certificated educators in terms of self-management

Outcomes

Primary Outcomes

Change in Self-care behaviour

Time Frame: At baseline and 1 week, 3 months and 9 months after the intervention

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.

Change in Quality of life

Time Frame: At baseline and 1 week, 3 months and 9 months after the interventiont

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.

Change in Glycosylated hemoglobin(HbA1c) levels

Time Frame: At baseline and 1 week, 3 months and 9 months after the intervention

Collect from medical records

Secondary Outcomes

  • Change in Diabetes Self-efficacy(At baseline and 1 week, 3 months and 9 months after the interventiont)
  • Change in Diabetic Positive Characteristics(At baseline and 1 week, 3 months and 9 months after the intervention)
  • Change in Gratitude(At baseline and 1 week, 3 months and 9 months after the intervention)
  • Change in Diabetes Distress(At baseline and 1 week, 3 months and 9 months after the intervention)
  • Change in Optimism(At baseline and 1 week, 3 months and 9 months after the intervention)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Chieh-Hua Lu

director

Tri-Service General Hospital

Study Sites (1)

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