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

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ClinicalTrials.gov Identifier: NCT05174975
Recruitment Status : Recruiting
First Posted : January 3, 2022
Last Update Posted : January 3, 2022
Sponsor:
Collaborator:
Kaohsiung Medical University
Information provided by (Responsible Party):
Chieh-Hua Lu, Tri-Service General Hospital

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).

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Behavioral: App-based Positive Psychological Intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants are assigned to two groups in parallel for the duration of the study
Masking: Single (Outcomes Assessor)
Masking Description: outcome assessor will not know the group of participants
Primary Purpose: Treatment
Official Title: Tri-Service General Hospital, Department of Internal Medicine
Actual Study Start Date : October 20, 2021
Estimated Primary Completion Date : July 30, 2023
Estimated Study Completion Date : October 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: App-based Positive Psychological Intervention group
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
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.

No Intervention: control group
usual care which will educated by certificated educators in terms of self-management



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   20 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05174975


Contacts
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Contact: Shi-Yu CHEN 886287927184 sabrina540627@gmail.com
Contact: Ruey-Hsia Wang 886917560425 wrhsia@kmu.edu.tw

Locations
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Taiwan
Tri-Service General Hospital Recruiting
Taipei, Taiwan
Contact: Shi-Yu Chen, RN    006287927184    sabrina540627@gmail.com   
Contact: Ruey-Hsia Wang    886917560425    wrhsia@kmu.edu.tw   
Sponsors and Collaborators
Tri-Service General Hospital
Kaohsiung Medical University
Investigators
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Principal Investigator: Chieh-Hua Lu Tri-Service General Hospital
  Study Documents (Full-Text)

Documents provided by Chieh-Hua Lu, Tri-Service General Hospital:
Publications:

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Responsible Party: Chieh-Hua Lu, director, Tri-Service General Hospital
ClinicalTrials.gov Identifier: NCT05174975    
Other Study ID Numbers: B202105141
First Posted: January 3, 2022    Key Record Dates
Last Update Posted: January 3, 2022
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: depend on the finding and process of publication

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chieh-Hua Lu, Tri-Service General Hospital:
diabetes mellitus
self-care behaviors
quality of lofe
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases