Diabete Type 2NCT04120844
Effectiveness of Motivational Interviewing on Improving Care for Type 2 Diabetes Mellitus Patients in China
A study testing Motivational interviewing (MI)-based patient empowerment program (PEP) and Traditional lecture style health education in people with Diabete Type 2, run by The University of Hong Kong-Shenzhen Hospital.
Trial summary
The International Diabetes Federation estimated that there were nearly 110 million diabetes mellitus (DM) patients in China, which was the highest number recorded in the world. In response to the rising patient numbers and costs, the Chinese government has invested heavily in primary healthcare, with the goal of… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabete Type 2
- What is being tested?
- Motivational interviewing (MI)-based patient empowerment program (PEP) and Traditional lecture style health education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 225 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2016to 26 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes with HbA1c between 7-10%
- 18-75 years old
- No known severe comorbidities or complications, such as cancer, unstable angina, frequent exacerbation of chronic obstructive pulmonary disease, or diabetic retinopathy
- Cognitively competent enough to understand written and the oral expression of the language native to the study site
Who cannot join
- Known severe comorbidities or complications, such as cancer, unstable angina, frequent exacerbation of chronic obstructive pulmonary disease, or diabetic retinopathy
- Illiterate, or cognitively competent enough to understand written and the oral expression of the language native to the study site
About this study
Official title: Effectiveness of Motivational Interviewing on Improving Care for Patients With Type 2 Diabetes in China: A Randomized Controlled Trial
The International Diabetes Federation estimated that there were nearly 110 million diabetes mellitus (DM) patients in China, which was the highest number recorded in the world. In response to the rising patient numbers and costs, the Chinese government has invested heavily in primary healthcare, with the goal of improving chronic disease management in the primary care settings. A key part of the primary care improvement program prioritizes health education as a route to lifestyle modification. Although the content and modes of delivery vary enormously, most of the programs focused on providing information rather than facilitating patient change. The impacts of traditional patient education on lifestyle modification and changes in psychological status have been reported to be suboptimal. It is therefore necessary to rethink and explore a more structured, patient-centered approach to health education at improving the outcomes of DM control.
Motivational interviewing (MI) is a collaborative, patient-centered counseling approach that aims to elicit behavior change.The focus of MI is to find and resolve the ambivalence, improve patients' perception of the importance of behavior change, and support them to make the change. MI provides a structural framework with guiding principles that can be easily followed by the primary care doctors. Some studies show that MI can contribute to improve healthy eating, weight control and increases in physical activity, but most research focused on intermediate outcome measures and did not evaluate the readiness to change. MI can be utilized by a variety of healthcare providers, which makes it adaptable for different culture and clinical settings. The effectiveness of MI in Chinese diabetic patients remains uncertain.Therefore, in this study, we adopted the group MI approach and developed a patient empowerment program (PEP) utilizing the techniques and framework of MI. We compared this to the most common form of DM education in China, a lecture on DM to patients and their carers in a hospital lecture theatre in a didactic manner. The study aimed to assess the effectiveness of the MI approach in terms of patient lifestyle modification and improving DM controls compared to the control group in a non-blinded randomized controlled trial (RCT) design.
Read the detailed description
This RCT was implemented from May 2016 to April 2017 in Shenzhen, China. Shenzhen is the fourth-biggest city in China, with a rapidly expanding population of 12 million people and the highest GDP in the country. Most DM patients in China are managed at Endocrine Specialist hospital clinics, while the more stable patients are treated in the community. Therefore, we chose an endocrine specialist outpatient clinic and a family medicine clinic at the University of Hong Kong-Shenzhen Hospital (HKU-SZH), as well as three community health centers in the Luohu district as the sampling frame. DM patients were recruited by doctors at consultations. This is because health education lectures are one of the routine diabetes management strategies used by healthcare providers in China and patients are normally invited by their doctors to attend these lectures.
Sample size estimation was calculated based on the previous published research conducted elsewhere in which the DM patients were given MI-guided behavior change counselling. The "Problem Areas in Diabetes" (PAID) score in that study was 29±22.64 in the intervention group vs. 29±24.32 in the control group. Therefore, 192 participants were needed to detect 10% effect size with an alpha of 0.05 and a power of 80.0%. With 15% of loss to follow-up anticipated, a total of 225 participants were targeted.
Descriptive statistics were used to summarize characteristics of the participants. We analyzed the baseline data of the intervention and control groups to determine the consistency of the characteristics across the two groups of patients. The t-test was used for continuous variables such as waist circumference, body weight, and BMI, whereas chi-squared test was used for categorical variables in stages of change such as smoking, drinking, and exercise. Changes in PAID and PEI in post-intervention and follow-ups between the two groups were calculated and tested.
When analyzing the two sets of variables in the intervention and control groups, we followed the principle of intent-to-treat analysis i.e. if the participant failed to participate in all four modules, the first questionnaire results would be assumed and analyzed as the final data, using the mixed design analysis of variance. In detecting the relationship between the continuity variable and categorical variable, we used bivariate correlation analyses. All analyses were performed in SPSS 20.0. We used p value<0.05 as the cut-off point of statistical significance.
- Conditions
- Diabete Type 2
- Being tested
- Motivational interviewing (MI)-based patient empowerment program (PEP), Traditional lecture style health education
- Keywords
- Type 2 diabete, Motivational interviewing, Patient empowerment, Self-management, China
- Medical subject headings
- Diabetes Mellitus, Type 2, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational interviewing (MI)-based patient empowerment program (PEP)Behavioural
Motivational interviewing (MI) is a collaborative, patient-centered counseling approach that aims to elicit behavior change. Counselors use empathy and other techniques to create an atmosphere to help patients to explore the discrepancies between the goals and their current behavior. The focus of MI is to find and resolve the ambivalence, improve patients' perception of the importance of behavior change, and support them to make the change. MI provides a structural framework with guiding principles that can be easily followed by the primary care doctors. Program content was further informed by the Hospital Authority Patient Empowerment Program in Hong Kong. The education program consisted of four modules, held once a week, that each lasted approximately 1½ to 2 hours. They were grouped under the following four broad headings: Knowing Diabetes, Diabetes Self-Care, Healthy Diet and Physical Exercise.
Traditional lecture style health educationBehavioural
The control group received traditional lectures that consisted solely of conveying healthcare information to patients. In order to minimize intervention bias, the control group lectures were standardized and adapted into four modules, namely knowing diabetes, healthy diet, physical exercises, and how to use medication correctly, which were similar topic headings, durations and frequencies to those of the intervention group. Each lecture was 1 hour and was provided by one of four health professionals (a pharmacist, dietician, endocrinologist or nurse) who had never received any prior training in MI. We consciously avoided the inclusion of elements of self-reflection and motivation in these lectures.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Patients in the intervention group (n=117) received a four-session PEP in small groups over one month by trained nurses and doctors. Receives: Behavioral: Motivational interviewing (MI)-based patient empowerment program (PEP) |
| Control | Placebo comparator | The control group (n=108) received the traditional lecture-style health education on Diabetes Mellitus. Receives: Behavioral: Traditional lecture style health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Problem Areas in Diabetic (PAID) Questionnaire
PAID is a self-administered 20-item scale. Each item is scored from 0 (not a problem) to 4 (serious problem). The sum of all item scores multiplied by 1.25 gives the total PAID score, which ranges from 0 to 100, higher scores reflecting greater emotional distress. A score of 40 or above is indicative of severe emotional distress.
Measured: 3 months
Secondary outcomes (2)
"Patient Enablement Index" (PEI) score
The PEI is a scale that measures patients' enablement, it was also used to measure patient enablement in this study.Subjects with PEI total score> 0 are considered to have enablement over the past 12-month period, while those with PEI total score = 0 were considered to have no enablement over the period. The PEI scale had been validated in the Chinese population.
Measured: 3 months
Stages of Change score
Motivation for lifestyle change was measured in this study based on the "Stages of Change" model to assess participants' readiness to change in behaviors such as smoking, drinking or exercise and their adherence to treatment. The mean stage-of-change score may be a more stable estimate of stage of change.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2019
- Study start1 May 2016
- Primary completion1 Apr 2017
- Study completion26 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabete Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong-Shenzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jingya Yan, Principal investigator, The University of Hong Kong-Shenzhen HospitalWei Liang, Principal investigator, The University of Hong Kong - Shenzhen Hospital, Shenzhen, China.Chen Qingqi, Principal investigator, The University of Hong Kong-Shenzhen HospitalWong Chi Wai William, Principal investigator, The University of Hong Kong-Shenzhen HospitalJennifer Li, Principal investigator, The University of Hong Kong-Shenzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04120844
- Sponsor's protocol ID
- JCYJ20150331142757385
- Status last verified
- Oct 2019
- First submitted
- 26 Sep 2019
- Last updated
- 9 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Subject to principal investigator's approval
Publications
Li Z, Chen Q, Yan J, Liang W, Wong WCW. Effectiveness of motivational interviewing on improving Care for Patients with type 2 diabetes in China: A randomized controlled trial. BMC Health Serv Res. 2020 Jan 23;20(1):57. doi: 10.1186/s12913-019-4776-8.
PubMed 31973759
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Motivational Interviewing on Improving Care for Patients With Type 2 Diabetes in China: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04120844
- Acronym / sponsor ID
- JCYJ20150331142757385
- Conditions
- Diabete Type 2
- Keywords
- Type 2 diabete, Motivational interviewing, Patient empowerment, Self-management, China
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- The University of Hong Kong-Shenzhen HospitalUniversity, hospital or other
- Study start
- 1 May 2016 (actual)
- Primary completion
- 1 Apr 2017 (actual)
- Study completion
- 26 Sep 2019 (actual)
- First posted
- 9 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The International Diabetes Federation estimated that there were nearly 110 million diabetes mellitus (DM) patients in China, which was the highest number recorded in the world. In response to the rising patient numbers and costs, the Chinese government has invested heavily in primary healthcare, with the goal of improving chronic disease management in the primary care settings. A key part of the primary care improvement program prioritizes health education as a route to lifestyle modification. Although the content and modes of delivery vary enormously, most of the programs focused on providing information rather than facilitating patient change. The impacts of traditional patient education on lifestyle modification and changes in psychological status have been reported to be suboptimal. It is therefore necessary to rethink and explore a more structured, patient-centered approach to health education at improving the outcomes of DM control.
Motivational interviewing (MI) is a collaborative, patient-centered counseling approach that aims to elicit behavior change.The focus of MI is to find and resolve the ambivalence, improve patients' perception of the importance of behavior change, and support them to make the change. MI provides a structural framework with guiding principles that can be easily followed by the primary care doctors. Some studies show that MI can contribute to improve healthy eating, weight control and increases in physical activity, but most research focused on intermediate outcome measures and did not evaluate the readiness to change. MI can be utilized by a variety of healthcare providers, which makes it adaptable for different culture and clinical settings. The effectiveness of MI in Chinese diabetic patients remains uncertain.Therefore, in this study, we adopted the group MI approach and developed a patient empowerment program (PEP) utilizing the techniques and framework of MI. We compared this to the most common form of DM education in China, a lecture on DM to patients and their carers in a hospital lecture theatre in a didactic manner. The study aimed to assess the effectiveness of the MI approach in terms of patient lifestyle modification and improving DM controls compared to the control group in a non-blinded randomized controlled trial (RCT) design.
Detailed description
This RCT was implemented from May 2016 to April 2017 in Shenzhen, China. Shenzhen is the fourth-biggest city in China, with a rapidly expanding population of 12 million people and the highest GDP in the country. Most DM patients in China are managed at Endocrine Specialist hospital clinics, while the more stable patients are treated in the community. Therefore, we chose an endocrine specialist outpatient clinic and a family medicine clinic at the University of Hong Kong-Shenzhen Hospital (HKU-SZH), as well as three community health centers in the Luohu district as the sampling frame. DM patients were recruited by doctors at consultations. This is because health education lectures are one of the routine diabetes management strategies used by healthcare providers in China and patients are normally invited by their doctors to attend these lectures.
Sample size estimation was calculated based on the previous published research conducted elsewhere in which the DM patients were given MI-guided behavior change counselling. The "Problem Areas in Diabetes" (PAID) score in that study was 29±22.64 in the intervention group vs. 29±24.32 in the control group. Therefore, 192 participants were needed to detect 10% effect size with an alpha of 0.05 and a power of 80.0%. With 15% of loss to follow-up anticipated, a total of 225 participants were targeted.
Descriptive statistics were used to summarize characteristics of the participants. We analyzed the baseline data of the intervention and control groups to determine the consistency of the characteristics across the two groups of patients. The t-test was used for continuous variables such as waist circumference, body weight, and BMI, whereas chi-squared test was used for categorical variables in stages of change such as smoking, drinking, and exercise. Changes in PAID and PEI in post-intervention and follow-ups between the two groups were calculated and tested.
When analyzing the two sets of variables in the intervention and control groups, we followed the principle of intent-to-treat analysis i.e. if the participant failed to participate in all four modules, the first questionnaire results would be assumed and analyzed as the final data, using the mixed design analysis of variance. In detecting the relationship between the continuity variable and categorical variable, we used bivariate correlation analyses. All analyses were performed in SPSS 20.0. We used p value<0.05 as the cut-off point of statistical significance.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Motivational interviewing (MI)-based patient empowerment program (PEP)Patients in the intervention group (n=117) received a four-session PEP in small groups over one month by trained nurses and doctors. |
| Control | Placebo comparator | Behavioral: Traditional lecture style health educationThe control group (n=108) received the traditional lecture-style health education on Diabetes Mellitus. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Type 2 diabetes with HbA1c between 7-10%
- 18-75 years old
- No known severe comorbidities or complications, such as cancer, unstable angina, frequent exacerbation of chronic obstructive pulmonary disease, or diabetic retinopathy
- Cognitively competent enough to understand written and the oral expression of the language native to the study site
Key exclusion criteria (2 listed)
- Known severe comorbidities or complications, such as cancer, unstable angina, frequent exacerbation of chronic obstructive pulmonary disease, or diabetic retinopathy
- Illiterate, or cognitively competent enough to understand written and the oral expression of the language native to the study site
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational interviewing (MI)-based patient empowerment program (PEP)Motivational interviewing (MI) is a collaborative, patient-centered counseling approach that aims to elicit behavior change. Counselors use empathy and other techniques to create an atmosphere to help patients to explore the discrepancies between the goals and their current behavior. The focus of MI is to find and resolve the ambivalence, improve patients' perception of the importance of behavior change, and support them to make the change. MI provides a structural framework with guiding principles that can be easily followed by the primary care doctors. Program content was further informed by the Hospital Authority Patient Empowerment Program in Hong Kong. The education program consisted of four modules, held once a week, that each lasted approximately 1½ to 2 hours. They were grouped under the following four broad headings: Knowing Diabetes, Diabetes Self-Care, Healthy Diet and Physical Exercise. | Behavioural | Intervention |
| Traditional lecture style health educationThe control group received traditional lectures that consisted solely of conveying healthcare information to patients. In order to minimize intervention bias, the control group lectures were standardized and adapted into four modules, namely knowing diabetes, healthy diet, physical exercises, and how to use medication correctly, which were similar topic headings, durations and frequencies to those of the intervention group. Each lecture was 1 hour and was provided by one of four health professionals (a pharmacist, dietician, endocrinologist or nurse) who had never received any prior training in MI. We consciously avoided the inclusion of elements of self-reflection and motivation in these lectures. | Behavioural | Control |
Primary outcome
Problem Areas in Diabetic (PAID) Questionnaire
Time frame: 3 months
PAID is a self-administered 20-item scale. Each item is scored from 0 (not a problem) to 4 (serious problem). The sum of all item scores multiplied by 1.25 gives the total PAID score, which ranges from 0 to 100, higher scores reflecting greater emotional distress. A score of 40 or above is indicative of severe emotional distress.
2 secondary outcomes
"Patient Enablement Index" (PEI) score
Time frame: 3 months
Stages of Change score
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2019.
- Derived from this study: PubMed 31973759Li Z, Chen Q, Yan J, Liang W, Wong WCW. Effectiveness of motivational interviewing on improving Care for Patients with type 2 diabetes in China: A randomized controlled trial. BMC Health Serv Res. 2020 Jan 23;20(1):57. doi: 10.1186/s12913-019-4776-8.
- Individual participant dataSharing planned: Yes. Subject to principal investigator's approval
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jingya Yan principal investigator
The University of Hong Kong-Shenzhen Hospital
Wei Liang principal investigator
The University of Hong Kong - Shenzhen Hospital, Shenzhen, China.
Chen Qingqi principal investigator
The University of Hong Kong-Shenzhen Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Motivational interviewing (MI)-based patient empowerment program (PEP) and Traditional lecture style health education in people with Diabete Type 2, run by The University of Hong Kong-Shenzhen Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Problem Areas in Diabetic (PAID) Questionnaire (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04120844, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2019.