DiabetesNCT02733315
Effectiveness of the Diabetes Conversation Map Program Among Diabetic Patients in Taiwan
A study testing Diabetes Conversation Map Program in people with Diabetes, run by Dalin Tzu Chi General Hospital.
Trial summary
The Diabetes Conversation Map Program (DCMP) is a novel, group-based, interactive diabetes management education program that has been shown to help patients adapt to their disease. So the investigators aimed to examine the long-term effectiveness of the DCMP among diabetes patients in Taiwan. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Diabetes
- What is being tested?
- Diabetes Conversation Map Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Dec 2014
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- being at least 20 years old at the time of recruitment,
- having no cognitive impairment and severe complications,
- being able to express opinions in either Mandarin or Taiwanese, and
- having a diagnosis of DM.
Who cannot join
- being unwillingness to participant this work
- Attending the similar health education program in the past
About this study
Official title: Long-term Effectiveness of the Diabetes Conversation Map Program: A Pre-post Education Intervention Study Among Diabetic Patients in Taiwan
The Diabetes Conversation Map Program (DCMP) is a novel, group-based, interactive diabetes management education program that has been shown to help patients adapt to their disease. So the investigators aimed to examine the long-term effectiveness of the DCMP among diabetes patients in Taiwan.
Read the detailed description
Study design and participants
A quasi-experimental pre-posttest control group design, with purposive sampling, was used to recruit participants from the Endocrinology department of a hospital in southern Taiwan from January to May of 2014. The inclusion criteria were (i) being at least 20 years old at the time of recruitment (ii) having no cognitive impairment and severe complications, (iii) being able to express opinions in either Mandarin or Taiwanese, and (iv) having a diagnosis of diabetes. To ensure participants' anonymity, all questionnaires were marked with an encryption code to facilitate data analysis, but with no personal identifiers.
Sample size calculation
Sample size calculation for this analysis of repeated measures to detect an effect size of 0.2 at 80% power and a 0.05 significance level indicated that a sample size of 68 patients is needed (according to G- POWER 3.1 analytical software, Franz Faul, Universitat Kiel, Germany). A sample of at least 89 participants for both groups combined was required on the basis of these parameters, allowing for a 30% attrition rate.
Intervention
Because continued participation was essential for this study, the participants were divided into the experiment or control group in accordance with the personal willingness. The control group received routine health education lasting for about 30 minutes per medical visit, which consisted of consultation about disease symptoms, related treatments, and self-care skills. They would receive health education instruction leaflets for reference purposes if necessary.
The experiment group received seven Diabetes Conversation Map Program (DCMP) -based group education sessions (10-12 participants, 1.5 hours each) for seven consecutive weeks in addition to routine health education at a private room in the outpatient unit. One registered nurse who received DCMP facilitator training, from the Taiwanese Association of Diabetic Educators, served as the class facilitator. DCMP sessions were conducted using seven colored "maps" covering different topics, including "walk with diabetes," "what is diabetes?", "a healthy diet and exercise," "walk with insulin," "diabetes complications and related risk factors," "foot care for diabetes patients," and "a type 1 diabetes patient in the home." Each map, a laminated 3-by-5-foot table-top visual with colorful drawings as metaphors of situations familiar to DM patients, was placed on a table with participants gathered around it. This procedure served to create mutual imagery to be shared with participants. In addition to using these colored maps, the facilitator further offered participants self-designed conversation cards and asked them to share individual glycemic control experiences based on the questions shown on the cards.
Outcome measures
The primary outcomes comprised the weekly self-monitoring of blood glucose (SMBG) times and some biochemical parameters containing BMI, HbA1c and fasting plasma glucose (FPG). In addition, the depressive symptoms as well as the level of diabetes health literacy were also measured, which were determined by the Taiwanese Depression Questionnaire (TDQ) and a self-administered questionnaire regarding diabetes health literacy.
The TDQ was developed according to the criteria specified by the Diagnostic and Statistical Manual of Mental Disorders (Third Edition) and consists of 18 self-reported items. Its total score ranged from 0 to 54, with higher scores indicating more severe depressive symptoms.
On the other hand, as to the diabetes health literacy, it was measured by a self-developed questionnaire. This scale contained 20 items and was scored using a 5-point Likert scale, with higher total scores indicating more positive diabetic health literacy.
Covariates Additional items addressing demographic and disease characteristics were developed based on clinical experience and literature review, and were collected at study entry via patient interviews and medical records. Demographic data included sex, age, marital status, education level, religion, household status, monthly income, and certain lifestyle factors, such as smoking, exercise habits, and presence of sleep disturbances. Smoking status was recorded as "non-smoker" or "current or ex-smoker." Those who exercised regularly (i.e., weekly) were classified as having "exercise habits." Sleep disturbances were defined as waking up at night more than twice without external factors during the week before the interview. Disease characteristics included the presence of chronic disease (i.e., stroke, hypertension, heart disease, renal disease, or cancer), medication regimen, and duration of diabetes.
Data collection procedure
The study protocol was approved by the Ethics Committee of Dalin Tzuchi Hospital (No. B10002009) prior to the recruitment of participants. Researchers explained the purpose of study and its procedure to all participants. Signed informed consent was obtained after they understood and agreed to participate in this study. Thereafter, investigators applied an observer-blind approach for data collection. A trained interviewer, who was not familiar with the participants, was assigned to collect the participants' information on demographic and disease characteristics. All data were obtained at three time points: before DCMP (T0), three days after DCMP (T1), and three months after DCMP (T2). To reduce the dropout rate, researchers asked participants to return the hospital for the completion of assessments via phone reminders. However, participants were still given the option to withdraw from the study at any time without any penalty.
Statistical analysis
Descriptive and inferential statistical analyses were conducted in accordance with the study aims and the nature of the variables. Descriptive parameters, including mean, standard deviation (SD), and percentage, were used to describe the distributions of demographic and disease data. Differences between the two groups were compared initially using t-test and χ2 test as appropriate. For inferential analysis, investigators used generalized estimating equation (GEE) procedure with identity link function with normal distribution to assess the long-term effects of DCMP, while taking into account within-subject correlations between measurements over time and the influence of potential confounding covariates. All analyses were conducted using SAS statistical software, Version 9.3. A p value of < .05 was considered statistically significant.
- Conditions
- Diabetes
- Being tested
- Diabetes Conversation Map Program
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetes Conversation Map ProgramBehavioural
The experiment group received seven DCMP-based group education sessions for seven consecutive weeks in addition to routine health education at a private room in the outpatient unit. One registered nurse who received DCMP facilitator training, from the Taiwanese Association of Diabetic Educators, served as the class facilitator. DCMP sessions were conducted using seven colored "maps" covering different topics, including "walk with diabetes," "what is diabetes?", "a healthy diet and exercise," "walk with insulin," "diabetes complications and related risk factors," "foot care for diabetes patients," and "a type 1 diabetes patient in the home." Each map, a laminated 3-by-5-foot table-top visual with colorful drawings as metaphors of situations familiar to DM patients, was placed on a table with participants gathered around it. This procedure served to create mutual imagery to be shared with participants.
| Study group | Role | What they receive |
|---|---|---|
| DCMP | Experimental | Not described Receives: Behavioral: Diabetes Conversation Map Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weekly self-monitoring of blood glucose times as determined by medical chart review
Measured: Up to nine months
Secondary outcomes (5)
Body mass index as determined by medical chart review
Measured: Up to nine months
The depressive symptoms level as measured by Taiwanese Depression Questionnaire
Measured: Up to nine months
Level of DM health literacy as measured by the self-developed questionnaire
Measured: Up to nine months
HbA1c as determined by medical chart review
Measured: Up to nine months
fasting plasma glucose as determined by medical chart review
Measured: Up to nine months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2016 (estimated)
- Study startJan 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dalin Tzu Chi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tzung-Yi Tsai, Dalin Tzu Chi General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02733315
- Sponsor's protocol ID
- DTCRD103-I-04
- Status last verified
- Apr 2016
- First submitted
- 1 Apr 2016
- Last updated
- 12 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Effectiveness of the Diabetes Conversation Map Program: A Pre-post Education Intervention Study Among Diabetic Patients in Taiwan
- ClinicalTrials.gov ID
- NCT02733315
- Acronym / sponsor ID
- DTCRD103-I-04
- Conditions
- Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Dalin Tzu Chi General HospitalUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 11 Apr 2016 (estimated)
- 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 Diabetes Conversation Map Program (DCMP) is a novel, group-based, interactive diabetes management education program that has been shown to help patients adapt to their disease. So the investigators aimed to examine the long-term effectiveness of the DCMP among diabetes patients in Taiwan.
Detailed description
Study design and participants
A quasi-experimental pre-posttest control group design, with purposive sampling, was used to recruit participants from the Endocrinology department of a hospital in southern Taiwan from January to May of 2014. The inclusion criteria were (i) being at least 20 years old at the time of recruitment (ii) having no cognitive impairment and severe complications, (iii) being able to express opinions in either Mandarin or Taiwanese, and (iv) having a diagnosis of diabetes. To ensure participants' anonymity, all questionnaires were marked with an encryption code to facilitate data analysis, but with no personal identifiers.
Sample size calculation
Sample size calculation for this analysis of repeated measures to detect an effect size of 0.2 at 80% power and a 0.05 significance level indicated that a sample size of 68 patients is needed (according to G- POWER 3.1 analytical software, Franz Faul, Universitat Kiel, Germany). A sample of at least 89 participants for both groups combined was required on the basis of these parameters, allowing for a 30% attrition rate.
Intervention
Because continued participation was essential for this study, the participants were divided into the experiment or control group in accordance with the personal willingness. The control group received routine health education lasting for about 30 minutes per medical visit, which consisted of consultation about disease symptoms, related treatments, and self-care skills. They would receive health education instruction leaflets for reference purposes if necessary.
The experiment group received seven Diabetes Conversation Map Program (DCMP) -based group education sessions (10-12 participants, 1.5 hours each) for seven consecutive weeks in addition to routine health education at a private room in the outpatient unit. One registered nurse who received DCMP facilitator training, from the Taiwanese Association of Diabetic Educators, served as the class facilitator. DCMP sessions were conducted using seven colored "maps" covering different topics, including "walk with diabetes," "what is diabetes?", "a healthy diet and exercise," "walk with insulin," "diabetes complications and related risk factors," "foot care for diabetes patients," and "a type 1 diabetes patient in the home." Each map, a laminated 3-by-5-foot table-top visual with colorful drawings as metaphors of situations familiar to DM patients, was placed on a table with participants gathered around it. This procedure served to create mutual imagery to be shared with participants. In addition to using these colored maps, the facilitator further offered participants self-designed conversation cards and asked them to share individual glycemic control experiences based on the questions shown on the cards.
Outcome measures
The primary outcomes comprised the weekly self-monitoring of blood glucose (SMBG) times and some biochemical parameters containing BMI, HbA1c and fasting plasma glucose (FPG). In addition, the depressive symptoms as well as the level of diabetes health literacy were also measured, which were determined by the Taiwanese Depression Questionnaire (TDQ) and a self-administered questionnaire regarding diabetes health literacy.
The TDQ was developed according to the criteria specified by the Diagnostic and Statistical Manual of Mental Disorders (Third Edition) and consists of 18 self-reported items. Its total score ranged from 0 to 54, with higher scores indicating more severe depressive symptoms.
On the other hand, as to the diabetes health literacy, it was measured by a self-developed questionnaire. This scale contained 20 items and was scored using a 5-point Likert scale, with higher total scores indicating more positive diabetic health literacy.
Covariates Additional items addressing demographic and disease characteristics were developed based on clinical experience and literature review, and were collected at study entry via patient interviews and medical records. Demographic data included sex, age, marital status, education level, religion, household status, monthly income, and certain lifestyle factors, such as smoking, exercise habits, and presence of sleep disturbances. Smoking status was recorded as "non-smoker" or "current or ex-smoker." Those who exercised regularly (i.e., weekly) were classified as having "exercise habits." Sleep disturbances were defined as waking up at night more than twice without external factors during the week before the interview. Disease characteristics included the presence of chronic disease (i.e., stroke, hypertension, heart disease, renal disease, or cancer), medication regimen, and duration of diabetes.
Data collection procedure
The study protocol was approved by the Ethics Committee of Dalin Tzuchi Hospital (No. B10002009) prior to the recruitment of participants. Researchers explained the purpose of study and its procedure to all participants. Signed informed consent was obtained after they understood and agreed to participate in this study. Thereafter, investigators applied an observer-blind approach for data collection. A trained interviewer, who was not familiar with the participants, was assigned to collect the participants' information on demographic and disease characteristics. All data were obtained at three time points: before DCMP (T0), three days after DCMP (T1), and three months after DCMP (T2). To reduce the dropout rate, researchers asked participants to return the hospital for the completion of assessments via phone reminders. However, participants were still given the option to withdraw from the study at any time without any penalty.
Statistical analysis
Descriptive and inferential statistical analyses were conducted in accordance with the study aims and the nature of the variables. Descriptive parameters, including mean, standard deviation (SD), and percentage, were used to describe the distributions of demographic and disease data. Differences between the two groups were compared initially using t-test and χ2 test as appropriate. For inferential analysis, investigators used generalized estimating equation (GEE) procedure with identity link function with normal distribution to assess the long-term effects of DCMP, while taking into account within-subject correlations between measurements over time and the influence of potential confounding covariates. All analyses were conducted using SAS statistical software, Version 9.3. A p value of < .05 was considered statistically significant.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DCMP | Experimental | Behavioral: Diabetes Conversation Map Program |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- being at least 20 years old at the time of recruitment,
- having no cognitive impairment and severe complications,
- being able to express opinions in either Mandarin or Taiwanese, and
- having a diagnosis of DM.
Key exclusion criteria (2 listed)
- being unwillingness to participant this work
- Attending the similar health education program in the past
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 |
|---|---|---|
| Diabetes Conversation Map ProgramThe experiment group received seven DCMP-based group education sessions for seven consecutive weeks in addition to routine health education at a private room in the outpatient unit. One registered nurse who received DCMP facilitator training, from the Taiwanese Association of Diabetic Educators, served as the class facilitator. DCMP sessions were conducted using seven colored "maps" covering different topics, including "walk with diabetes," "what is diabetes?", "a healthy diet and exercise," "walk with insulin," "diabetes complications and related risk factors," "foot care for diabetes patients," and "a type 1 diabetes patient in the home." Each map, a laminated 3-by-5-foot table-top visual with colorful drawings as metaphors of situations familiar to DM patients, was placed on a table with participants gathered around it. This procedure served to create mutual imagery to be shared with participants. | Behavioural | DCMP |
Primary outcome
Weekly self-monitoring of blood glucose times as determined by medical chart review
Time frame: Up to nine months
5 secondary outcomes
Body mass index as determined by medical chart review
Time frame: Up to nine months
The depressive symptoms level as measured by Taiwanese Depression Questionnaire
Time frame: Up to nine months
Level of DM health literacy as measured by the self-developed questionnaire
Time frame: Up to nine months
HbA1c as determined by medical chart review
Time frame: Up to nine months
fasting plasma glucose as determined by medical chart review
Time frame: Up to nine 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 12 Apr 2016.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Diabetes Conversation Map Program in people with Diabetes, run by Dalin Tzu Chi General 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 12 Apr 2016. 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. 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?
Weekly self-monitoring of blood glucose times as determined by medical chart review (time frame: Up to nine months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Apr 2016.