"Health in Mobile" for Community-dwelling Individuals With Chronic Diseases

Intervention Clinical Trial

Official title:

"Health in Mobile" - The e-Motivational-Interviewing Intervention for Community-dwelling Individuals With Chronic Diseases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05949320
• Other study ID #: HKSR T591
• Status: Recruiting
• Phase: N/A
• Start date: April 3, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: July 2023
• Source: Education University of Hong Kong
• Contact: Ho Yin Clive Wong, PhD
• Phone: 852-29488449
• Email: clivewong[@]eduhk.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to provide a mobile-apps-based intervention to facilitate individuals with chronic diseases such as high blood pressure and diabetes to adopt healthy behaviours. The intervention is based on Motivational Interviewing, a clinical technique used to enhance an individual's behavioural changes. The proposed research project comprises developing and validating the "Health in Mobile" app, which we call e-MI, which will then be launched to members of the three District Health Centre Express (DCHEs) who have presented with clinical/preclinical chronic health issues such as high blood pressure and diabetes. The participants are registered members of the three DCHEs. The targeted sample size is 1600 members, with 1200 are in the e-MI group while the other 400 are in the waiting list control group.

Description:

Motivational interviewing (MI) is a clinical technique used to enhance an individual's behavioral changes. The MI intervention shares a similar basis as the cognitive behavioral therapy based on the Stages of Change. It has been found effective for enabling individuals to tackle their problems in weight control, substance abuse, and smoking. The proposed study focuses on facilitating individuals with chronic diseases such as high blood pressure and diabetes to adopt health behaviors. The technique employed to facilitate the behavioral changes is the MI. Previous literature has reported the positive effects of MI in patients with chronic diseases. For instance, promoting weight loss in overweight and obese individuals, improving physical activity self-management in adults with type II diabetes, and regulation in blood pressure level among hypertensive individuals. However, the applications of the MI are mostly via the face-to-face method. Other application methods such as telephone coaching, online synchronous chat and mobile app are delivered as the alternative for communication. Individuals are engaged to enhance or modify certain behaviors via such as instant text interaction with psychologists, messages generated from a predefined system, and messages from interactive tools based on one's situation. Positive intervention effects were observed in these alternative forms of MI in terms of successful weight loss from a mobile app and telephone coaching and smoking cessation from telephone coaching. However, drawbacks include decreased attendance and engagement for lengthy programs, technical issues in delivering messages, and over-simplification of materials. The purpose of this study, therefore, is to deliver the MI to the participants with the use of perceptual learning theories, and the differential focuses on the cognitive and affective components when viewing simple MI messages via an app, and we name it the e-MI.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1600
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

Inclusion Criteria:

• 1) pass the cognitive screening test indicating low risk of mild cognitive impairment and depressive moods;
• 2) age 45 to 75 years;
• 3) completed primary school education or above;
• 4) has a considerate level of information literacy access to mobile phones and tablets;
• 5) agree to participate in the study and provide informed consent.

Exclusion Criteria:

• 1) participants with type 1 diabetes, impaired glucose tolerance, metabolic syndrome, maturity-onset diabetes of youth, or gestational diabetes;
• 2) clinical diagnosis of cardiovascular disease, kidney disease, liver disease, malignant tumour, or new-onset diabetes after organ transplant;
• 3) participants with a psychiatric or neurological disability

Related Conditions & MeSH terms

• Chronic Disease
• Control Group
• Intervention

Intervention

Other:
• e-Motivational Interviewing
This study evaluates a 90-day mobile phone-based intervention using the e-Motivational Interviewing app for individuals with chronic conditions like hypertension and diabetes. The app provides short conversations with health messages and reflective questions on lifestyle choices, such as physical activity and diet. The intervention incorporates "change talk" from Motivational Interviewing and principles from Basic Psychological Needs Theory (BPNT) to encourage positive behavior change. Users interact via multiple-choice questions, promoting self-assessment and reflection. The goal is to facilitate sustained lifestyle changes and improved health outcomes.

Locations

Country	Name	City	State
Hong Kong	Eastern District Health Centre Express	North Point
Hong Kong	Central and Western District Health Centre Express	Sai Ying Pun
Hong Kong	Sha Tin District Health Centre Express	Sha Tin

Sponsors (2)

Lead Sponsor	Collaborator
Education University of Hong Kong	The Hong Kong Society for Rehabilitation

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Chinese Affect Scale	The 12-item Chinese Affect Scale measures positive emotions and negative emotions of the day following each daily e-MI message delivery. Six items assess positive emotions and negative emotions, respectively (Hou et al., 2016). Participants will use a 11-point scale (0=very slightly or not at all, 5=moderately, 10=very much) to indicate the extent to which they were experiencing each emotional state at a sampling moment.	Baseline
Primary	The Chinese Affect Scale	The 12-item Chinese Affect Scale measures positive emotions and negative emotions of the day following each daily e-MI message delivery. Six items assess positive emotions and negative emotions, respectively (Hou et al., 2016). Participants will use a 11-point scale (0=very slightly or not at all, 5=moderately, 10=very much) to indicate the extent to which they were experiencing each emotional state at a sampling moment.	3 months
Primary	The Chinese Affect Scale	The 12-item Chinese Affect Scale measures positive emotions and negative emotions of the day following each daily e-MI message delivery. Six items assess positive emotions and negative emotions, respectively (Hou et al., 2016). Participants will use a 11-point scale (0=very slightly or not at all, 5=moderately, 10=very much) to indicate the extent to which they were experiencing each emotional state at a sampling moment.	9 months
Primary	The Chinese version of University of Rhode Island Change Assessment	The Chinese version of University of Rhode Island Change Assessment is a 32-item questionnaire to measure individuals' readiness for health-related changes for positive health-related behaviours.; The Chinese version of University of Rhode Island Change Assessment comprises 32 items that measure four stages of change. Participants rate each item on a 5-point Likert scale, ranging from 1 (strongly disagree) to 5 (strongly agree).To calculate the scores for each stage, sum the item scores for the corresponding items in each stage and divide by the number of items in that stage. This will provide an average score for each stage of change. Higher scores indicate a greater readiness for change at that specific stage.	Baseline
Primary	The Chinese version of University of Rhode Island Change Assessment	The Chinese version of University of Rhode Island Change Assessment is a 32-item questionnaire to measure individuals' readiness for health-related changes for positive health-related behaviours.; The Chinese version of University of Rhode Island Change Assessment comprises 32 items that measure four stages of change. Participants rate each item on a 5-point Likert scale, ranging from 1 (strongly disagree) to 5 (strongly agree).To calculate the scores for each stage, sum the item scores for the corresponding items in each stage and divide by the number of items in that stage. This will provide an average score for each stage of change. Higher scores indicate a greater readiness for change at that specific stage.	3 months
Primary	The Chinese version of University of Rhode Island Change Assessment	The Chinese version of University of Rhode Island Change Assessment is a 32-item questionnaire to measure individuals' readiness for health-related changes for positive health-related behaviours.; The Chinese version of University of Rhode Island Change Assessment comprises 32 items that measure four stages of change. Participants rate each item on a 5-point Likert scale, ranging from 1 (strongly disagree) to 5 (strongly agree).To calculate the scores for each stage, sum the item scores for the corresponding items in each stage and divide by the number of items in that stage. This will provide an average score for each stage of change. Higher scores indicate a greater readiness for change at that specific stage.	9 months
Primary	The International Physical Activity Questionnaire - Short Form	The International Physical Activity Questionnaire - Short Form measures participants' intensity and duration of physical activity in their daily lives, covering vigorous-intensity activities, moderate-intensity activities, walking, and sitting time.	Baseline
Primary	The International Physical Activity Questionnaire - Short Form	The International Physical Activity Questionnaire - Short Form measures participants' intensity and duration of physical activity in their daily lives, covering vigorous-intensity activities, moderate-intensity activities, walking, and sitting time.	3 months
Primary	The International Physical Activity Questionnaire - Short Form	The International Physical Activity Questionnaire - Short Form measures participants' intensity and duration of physical activity in their daily lives, covering vigorous-intensity activities, moderate-intensity activities, walking, and sitting time.	9 months
Primary	The standard 12-Item Short Form Health Survey	The SF-12 measures eight health domains, which can be grouped into two summary scores: Physical Component Summary (PCS) & Mental Component Summary (MCS).; Participants are asked to respond to each item considering their health status over the past four weeks. The response options vary depending on the item, with some questions having binary (yes/no) answers, and others using ordinal scales.; Each of the eight health domains is scored separately, with higher scores indicating better health. The scores for each domain are then standardized and weighted to calculate the PCS and MCS scores. Higher scores on the PCS and MCS represent better health-related quality of life.	Baseline
Primary	The standard 12-Item Short Form Health Survey	The SF-12 measures eight health domains, which can be grouped into two summary scores: Physical Component Summary (PCS) & Mental Component Summary (MCS).; Participants are asked to respond to each item considering their health status over the past four weeks. The response options vary depending on the item, with some questions having binary (yes/no) answers, and others using ordinal scales.; Each of the eight health domains is scored separately, with higher scores indicating better health. The scores for each domain are then standardized and weighted to calculate the PCS and MCS scores. Higher scores on the PCS and MCS represent better health-related quality of life.	3 months
Primary	The standard 12-Item Short Form Health Survey	The SF-12 measures eight health domains, which can be grouped into two summary scores: Physical Component Summary (PCS) & Mental Component Summary (MCS).; Participants are asked to respond to each item considering their health status over the past four weeks. The response options vary depending on the item, with some questions having binary (yes/no) answers, and others using ordinal scales.; Each of the eight health domains is scored separately, with higher scores indicating better health. The scores for each domain are then standardized and weighted to calculate the PCS and MCS scores. Higher scores on the PCS and MCS represent better health-related quality of life.	9 months
Primary	The Treatment Self-Regulation Questionnaire	The 15-item Treatment Self-Regulation Questionnaire will be used to assess the participants' motivation to perform health behaviors in terms of autonomous (intrinsically motivated) versus controlled (extrinsically motivated) over the past two weeks. Responses will range from 1 to 7 for each item (1=not at all true, 4=somewhat true, 7=very true) and will then be averaged to form the score for each self-regulation style (i.e., intrinsic vs. extrinsic).	Baseline
Primary	The Treatment Self-Regulation Questionnaire	The 15-item Treatment Self-Regulation Questionnaire will be used to assess the participants' motivation to perform health behaviors in terms of autonomous (intrinsically motivated) versus controlled (extrinsically motivated) over the past two weeks. Responses will range from 1 to 7 for each item (1=not at all true, 4=somewhat true, 7=very true) and will then be averaged to form the score for each self-regulation style (i.e., intrinsic vs. extrinsic).	3 months
Primary	The Treatment Self-Regulation Questionnaire	The 15-item Treatment Self-Regulation Questionnaire will be used to assess the participants' motivation to perform health behaviors in terms of autonomous (intrinsically motivated) versus controlled (extrinsically motivated) over the past two weeks. Responses will range from 1 to 7 for each item (1=not at all true, 4=somewhat true, 7=very true) and will then be averaged to form the score for each self-regulation style (i.e., intrinsic vs. extrinsic).	9 months
Primary	The Contemplation Ladder	The Contemplation Ladder is a visual analog scale designed as a ladder with 11 rungs, numbered from 0 to 10. Each rung represents a different level of readiness to change, ranging from no intention to change (0) to taking action to change (10).	Baseline
Primary	The Contemplation Ladder	The Contemplation Ladder is a visual analog scale designed as a ladder with 11 rungs, numbered from 0 to 10. Each rung represents a different level of readiness to change, ranging from no intention to change (0) to taking action to change (10).	3 months
Primary	The Contemplation Ladder	The Contemplation Ladder is a visual analog scale designed as a ladder with 11 rungs, numbered from 0 to 10. Each rung represents a different level of readiness to change, ranging from no intention to change (0) to taking action to change (10).	9 months
Primary	The Chinese version of the 7-item Generalized Anxiety Disorder scale	The Chinese version of the 7-item Generalized Anxiety Disorder scale will be used to assess anxiety symptoms in the past two weeks. Summed scores range from 0 to 21 (0 = not at all, 1 = on several days, 2 = on more than half of the days, 3 = nearly every day). Higher scores indicated greater severity of anxiety symptoms.	Baseline
Primary	The Chinese version of the 7-item Generalized Anxiety Disorder scale	The Chinese version of the 7-item Generalized Anxiety Disorder scale will be used to assess anxiety symptoms in the past two weeks. Summed scores range from 0 to 21 (0 = not at all, 1 = on several days, 2 = on more than half of the days, 3 = nearly every day). Higher scores indicated greater severity of anxiety symptoms.	3 months
Primary	The Chinese version of the 7-item Generalized Anxiety Disorder scale	The Chinese version of the 7-item Generalized Anxiety Disorder scale will be used to assess anxiety symptoms in the past two weeks. Summed scores range from 0 to 21 (0 = not at all, 1 = on several days, 2 = on more than half of the days, 3 = nearly every day). Higher scores indicated greater severity of anxiety symptoms.	9 months
Primary	Health Promotion Lifestyle Profile - II: Chinese version Short Form	Health Promotion Lifestyle Profile - II: Chinese version Short Form is a 30-item measure designed for reflecting health promotion lifestyle behaviors. Participants are asked to rate each item on a 4-point Likert scale, ranging from 1 (never) to 4 (routinely). To calculate the scores for each dimension, sum the item scores for the corresponding items in each dimension and divide by the number of items in that dimension. This will provide an average score for each dimension. Higher scores indicate better health-promoting behavior in that specific domain.	Baseline
Primary	Health Promotion Lifestyle Profile - II: Chinese version Short Form	Health Promotion Lifestyle Profile - II: Chinese version Short Form is a 30-item measure designed for reflecting health promotion lifestyle behaviors. Participants are asked to rate each item on a 4-point Likert scale, ranging from 1 (never) to 4 (routinely). To calculate the scores for each dimension, sum the item scores for the corresponding items in each dimension and divide by the number of items in that dimension. This will provide an average score for each dimension. Higher scores indicate better health-promoting behavior in that specific domain.	3 months
Primary	Health Promotion Lifestyle Profile - II: Chinese version Short Form	Health Promotion Lifestyle Profile - II: Chinese version Short Form is a 30-item measure designed for reflecting health promotion lifestyle behaviors. Participants are asked to rate each item on a 4-point Likert scale, ranging from 1 (never) to 4 (routinely). To calculate the scores for each dimension, sum the item scores for the corresponding items in each dimension and divide by the number of items in that dimension. This will provide an average score for each dimension. Higher scores indicate better health-promoting behavior in that specific domain.	9 months
Primary	Self-Reported Chronic Medical Conditions	Participants will report whether or not they currently have a list of chronic medical conditions, including but not limited to arthritis, hypertension, heart attack, chronic lung disease, stroke, diabetes, bladder disease, nephrolith, visual problems, hearing problems, and hemorrhoids.	Baseline
Primary	Self-Reported Chronic Medical Conditions	Participants will report whether or not they currently have a list of chronic medical conditions, including but not limited to arthritis, hypertension, heart attack, chronic lung disease, stroke, diabetes, bladder disease, nephrolith, visual problems, hearing problems, and hemorrhoids.	3 months
Primary	Self-Reported Chronic Medical Conditions	Participants will report whether or not they currently have a list of chronic medical conditions, including but not limited to arthritis, hypertension, heart attack, chronic lung disease, stroke, diabetes, bladder disease, nephrolith, visual problems, hearing problems, and hemorrhoids.	9 months
Primary	The Chinese version of the Satisfaction with Life Scale	The Chinese version of the Satisfaction with Life Scale will assess the participants' well-being in terms of satisfaction and fulfillment of their current state. Participants will indicate agreement with the content of five items on a 4-point scale (1=Strongly disagree, 4=Strongly agree). Scores will be calculated by summing across the items (range=5-20).	Baseline
Primary	The Chinese version of the Satisfaction with Life Scale	The Chinese version of the Satisfaction with Life Scale will assess the participants' well-being in terms of satisfaction and fulfillment of their current state. Participants will indicate agreement with the content of five items on a 4-point scale (1=Strongly disagree, 4=Strongly agree). Scores will be calculated by summing across the items (range=5-20).	3 months
Primary	The Chinese version of the Satisfaction with Life Scale	The Chinese version of the Satisfaction with Life Scale will assess the participants' well-being in terms of satisfaction and fulfillment of their current state. Participants will indicate agreement with the content of five items on a 4-point scale (1=Strongly disagree, 4=Strongly agree). Scores will be calculated by summing across the items (range=5-20).	9 months
Primary	The Chinese version of the nine-item Patient Health Questionnaire	The Chinese version of the nine-item Patient Health Questionnaire will be used to assess the depressive symptoms of the participants over the past two weeks on a 4-point scale (0=Not at all, 1=On several days, 2=More than half the days, 3=Nearly every day). Higher scores indicate a higher level of depressive symptoms (range=0-27).	Baseline
Primary	The Chinese version of the nine-item Patient Health Questionnaire	The Chinese version of the nine-item Patient Health Questionnaire will be used to assess the depressive symptoms of the participants over the past two weeks on a 4-point scale (0=Not at all, 1=On several days, 2=More than half the days, 3=Nearly every day). Higher scores indicate a higher level of depressive symptoms (range=0-27).	3 months
Primary	The Chinese version of the nine-item Patient Health Questionnaire	The Chinese version of the nine-item Patient Health Questionnaire will be used to assess the depressive symptoms of the participants over the past two weeks on a 4-point scale (0=Not at all, 1=On several days, 2=More than half the days, 3=Nearly every day). Higher scores indicate a higher level of depressive symptoms (range=0-27).	9 months
Primary	Eating Behaviour Questionnaire from the EatSmart Restaurant Star+ Campaign	The Eating Behaviours questionnaire is an assessment tool adapted from the EatSmart Restaurant Star+ Campaign, an initiative launched by the Department of Health in Hong Kong to promote healthy eating habits. The questionnaire focuses on various aspects of eating behaviors, such as the frequency of cooking at home, dining out, and the consumption patterns of different food groups, including red meat, white meat, fruits, and vegetables.	Baseline
Primary	Eating Behaviour Questionnaire from the EatSmart Restaurant Star+ Campaign	The Eating Behaviours questionnaire is an assessment tool adapted from the EatSmart Restaurant Star+ Campaign, an initiative launched by the Department of Health in Hong Kong to promote healthy eating habits. The questionnaire focuses on various aspects of eating behaviors, such as the frequency of cooking at home, dining out, and the consumption patterns of different food groups, including red meat, white meat, fruits, and vegetables.	3 months
Primary	Eating Behaviour Questionnaire from the EatSmart Restaurant Star+ Campaign	The Eating Behaviours questionnaire is an assessment tool adapted from the EatSmart Restaurant Star+ Campaign, an initiative launched by the Department of Health in Hong Kong to promote healthy eating habits. The questionnaire focuses on various aspects of eating behaviors, such as the frequency of cooking at home, dining out, and the consumption patterns of different food groups, including red meat, white meat, fruits, and vegetables.	9 months