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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Taiwan1 site
  • Pin-Fan Chen

    Chiayi City, Chiayi, 62247

Other trials in Taiwan

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.

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 groups in NCT06032429
Study groupRoleWhat they receive
Shared Medical AppointmentsExperimentalThis 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 careNo interventionRoutine health education without more advanced illustration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. the self-management level assessed by the self-developed scale

    Measured: up to six months

Secondary outcomes (1)
  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.

  1. First posted13 Sep 2023
  2. Study start1 Feb 2019
  3. Primary completion31 Dec 2020
  4. Study completion31 Dec 2020

Resources

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)
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

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.

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