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Completed

NCT Number: NCT05174975

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

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).

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Key information

Age range

20 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tri-Service General Hospital

Taipei, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

App-based Positive Psychological Intervention

Behavioral

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 outcomes

  1. 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.

  2. 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.

  3. 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

  1. Change in Diabetes Distress

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

    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.

  2. Change in Optimism

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

    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.

  3. Change in Gratitude

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

    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.

  4. Change in Diabetes Self-efficacy

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

    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.

  5. Change in Diabetic Positive Characteristics

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

    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.

Sponsors and collaborators

Lead sponsor

Tri-Service General Hospital (TSGH)

Other

Collaborators

  • Kaohsiung Medical University

Registry information

Official study title

Tri-Service General Hospital, Department of Internal Medicine

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jan 3, 2022
Registry last updated
Nov 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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