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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
App-based Positive Psychological Intervention
Sponsored by
Tri-Service General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring diabetes mellitus, self-care behaviors, quality of lofe

Eligibility Criteria

20 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tri-Service General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

App-based Positive Psychological Intervention group

control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.
Change in Glycosylated hemoglobin(HbA1c) levels
Collect from medical records

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
November 16, 2021
Last Updated
April 10, 2023
Sponsor
Tri-Service General Hospital
Collaborators
Kaohsiung Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05174975
Brief Title
Effectiveness of App-based Positive Psychological Intervention on Patients Newly Diagnosed With Type 2 Diabetes
Official Title
Tri-Service General Hospital, Department of Internal Medicine
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 20, 2021 (Actual)
Primary Completion Date
July 30, 2023 (Anticipated)
Study Completion Date
October 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tri-Service General Hospital
Collaborators
Kaohsiung Medical 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
diabetes mellitus, self-care behaviors, quality of lofe

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants are assigned to two groups in parallel for the duration of the study
Masking
Outcomes Assessor
Masking Description
outcome assessor will not know the group of participants
Allocation
Non-Randomized
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
App-based Positive Psychological Intervention group
Arm Type
Experimental
Arm Description
The intervention will be conducted on the app, including 2-week PPI, diabetes-related health education, physical records, and online consultation.
Arm Title
control group
Arm Type
No Intervention
Arm Description
usual care which will educated by certificated educators in terms of self-management
Intervention Type
Behavioral
Intervention Name(s)
App-based Positive Psychological Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Quality of life
Description
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.
Time Frame
At baseline and 1 week, 3 months and 9 months after the interventiont
Title
Change in Self-care behaviour
Description
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.
Time Frame
At baseline and 1 week, 3 months and 9 months after the intervention
Title
Change in Glycosylated hemoglobin(HbA1c) levels
Description
Collect from medical records
Time Frame
At baseline and 1 week, 3 months and 9 months after the intervention
Secondary Outcome Measure Information:
Title
Change in Diabetes Distress
Description
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.
Time Frame
At baseline and 1 week, 3 months and 9 months after the intervention
Title
Change in Optimism
Description
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.
Time Frame
At baseline and 1 week, 3 months and 9 months after the intervention
Title
Change in Gratitude
Description
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.
Time Frame
At baseline and 1 week, 3 months and 9 months after the intervention
Title
Change in Diabetes Self-efficacy
Description
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.
Time Frame
At baseline and 1 week, 3 months and 9 months after the interventiont
Title
Change in Diabetic Positive Characteristics
Description
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.
Time Frame
At baseline and 1 week, 3 months and 9 months after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shi-Yu CHEN
Phone
886287927184
Email
sabrina540627@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ruey-Hsia Wang
Phone
886917560425
Email
wrhsia@kmu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chieh-Hua Lu
Organizational Affiliation
Tri-Service General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tri-Service General Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shi-Yu Chen, RN
Phone
006287927184
Email
sabrina540627@gmail.com
First Name & Middle Initial & Last Name & Degree
Ruey-Hsia Wang
Phone
886917560425
Email
wrhsia@kmu.edu.tw

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
depend on the finding and process of publication
Citations:
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24048687
Citation
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Results Reference
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Results Reference
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Effectiveness of App-based Positive Psychological Intervention on Patients Newly Diagnosed With Type 2 Diabetes

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