Diabetes MellitusNCT06032429
Effects of Shared Medical Appointments for Diabetic Patients in Taiwan
A study testing Shared Medical Appointments in people with Diabetes Mellitus, run by Dalin Tzu Chi General Hospital at 1 site in Taiwan.
Trial summary
This quasi-experimental study is done to investigate the effect of Shared Medical Appointments (SMA) program for the diabetic patients in Taiwan. The relevant corresponding effects were determined via the generalized estimating equation (GEE) model. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Shared Medical Appointments
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Feb 2019to 31 Dec 2020
- 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 45 to 80 years
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of the Shared Medical Appointments on Blood Glucose and Self-care Efficacy for Middle-aged Patients With Type 2 Diabetes
This quasi-experimental study is done to investigate the effect of Shared Medical Appointments (SMA) program for the diabetic patients in Taiwan. The relevant corresponding effects were determined via the generalized estimating equation (GEE) model.
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 Jan to Dec in 2019. 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 0.4 at 80% power and a 0.05 significance level indicated that a sample size of 56 patients is needed (according to G- POWER 3.1 analytical software, Franz Faul, Universitat Kiel, Germany). A sample of at least 68 participants for both groups combined was required on the basis of these parameters, allowing for a 20% 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 four shared medical appointments (SMP) -based group education sessions (7-10 participants, 1.5 hours each) for four consecutive weeks in addition to routine health education at a private room in the outpatient unit. One registered nurse who received SMP facilitator training, from the Taiwanese Association of Diabetic Educators, served as the class facilitator. SMP sessions were conducted using several colored maps covering different topics, which included "healthy diet and exercises", "relevant treatment towards diabetic medications", " self-monitoring of blood glucose," and "treatment on hypoglycemia and hyperglycemia" . 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 were composed of two self-development tools, namely diabetic self-management questionnaire (DSMQ) as well as diabetic self-care questionnaire (DSCQ).
On the other hand, the consideration of covariates contained 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.
- Conditions
- Diabetes Mellitus
- Being tested
- Shared Medical Appointments
- Keywords
- Diabete Mellitus, Taiwan, effect
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shared Medical AppointmentsOther
Also called Standard care
SMA is a subset of such clinics and are defined by groups of patients meeting over time for comprehensive care for a defining chronic condition or health care state, which involved both a person trained or skilled in delivering patient education or facilitating patient interaction.
| Study group | Role | What they receive |
|---|---|---|
| Shared Medical Appointments | Experimental | This strategy is conducted by groups of patients meeting over time for comprehensive care, usually involving a practitioner with prescribing privileges, for a defining chronic condition or health care state. Meanwhile, this model often use educational and/or self-management enhancement strategies, paired with medication management, in an effort to achieve improved disease outcomes. Receives: Other: Shared Medical Appointments |
| Standard care | No intervention | Routine health education without more advanced illustration |
What is being measured
The primary outcome is the main question the study is designed to answer.
the self-management level assessed by the self-developed scale
Measured: up to six months
Secondary outcomes (1)
the self-care level assessed by the self-developed scale
Measured: up to six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start1 Feb 2019
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dalin Tzu Chi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pin-Fan Chen, Study director, Dalin Tzuchi Hospital, The Buddhist Tzuchi Medical Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06032429
- Sponsor's protocol ID
- B10703021
- Status last verified
- Sep 2023
- First submitted
- 23 Mar 2021
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Shared Medical Appointments on Blood Glucose and Self-care Efficacy for Middle-aged Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT06032429
- Acronym / sponsor ID
- B10703021
- Conditions
- Diabetes Mellitus
- Keywords
- Diabete Mellitus, Taiwan, effect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Dalin Tzu Chi General HospitalUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 13 Sep 2023 (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.
This quasi-experimental study is done to investigate the effect of Shared Medical Appointments (SMA) program for the diabetic patients in Taiwan. The relevant corresponding effects were determined via the generalized estimating equation (GEE) model.
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 Jan to Dec in 2019. 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 0.4 at 80% power and a 0.05 significance level indicated that a sample size of 56 patients is needed (according to G- POWER 3.1 analytical software, Franz Faul, Universitat Kiel, Germany). A sample of at least 68 participants for both groups combined was required on the basis of these parameters, allowing for a 20% 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 four shared medical appointments (SMP) -based group education sessions (7-10 participants, 1.5 hours each) for four consecutive weeks in addition to routine health education at a private room in the outpatient unit. One registered nurse who received SMP facilitator training, from the Taiwanese Association of Diabetic Educators, served as the class facilitator. SMP sessions were conducted using several colored maps covering different topics, which included "healthy diet and exercises", "relevant treatment towards diabetic medications", " self-monitoring of blood glucose," and "treatment on hypoglycemia and hyperglycemia" . 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 were composed of two self-development tools, namely diabetic self-management questionnaire (DSMQ) as well as diabetic self-care questionnaire (DSCQ).
On the other hand, the consideration of covariates contained 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shared Medical Appointments | Experimental | Other: Shared Medical AppointmentsThis strategy is conducted by groups of patients meeting over time for comprehensive care, usually involving a practitioner with prescribing privileges, for a defining chronic condition or health care state. Meanwhile, this model often use educational and/or self-management enhancement strategies, paired with medication management, in an effort to achieve improved disease outcomes. |
| Standard care | No intervention | –Routine health education without more advanced illustration |
Who may qualify
- Ages
- 45 to 80 years
- 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 |
|---|---|---|
| Shared Medical AppointmentsAlso: Standard careSMA is a subset of such clinics and are defined by groups of patients meeting over time for comprehensive care for a defining chronic condition or health care state, which involved both a person trained or skilled in delivering patient education or facilitating patient interaction. | Other | Shared Medical Appointments |
Primary outcome
the self-management level assessed by the self-developed scale
Time frame: up to six months
1 secondary outcome
the self-care level assessed by the self-developed scale
Time frame: up to six 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 13 Sep 2023.
- 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.
Pin-Fan Chen study director
Dalin Tzuchi Hospital, The Buddhist Tzuchi Medical Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shared Medical Appointments in people with Diabetes Mellitus, run by Dalin Tzu Chi General Hospital at 1 site in Taiwan.
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 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
the self-management level assessed by the self-developed scale (time frame: up to six 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 13 Sep 2023.