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Clinical Trials/NCT06032429
NCT06032429
Completed
N/A

Effects of the Shared Medical Appointments on Blood Glucose and Self-care Efficacy for Middle-aged Patients With Type 2 Diabetes

Dalin Tzu Chi General Hospital1 site in 1 country70 target enrollmentFebruary 1, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Diabetes Mellitus
Sponsor
Dalin Tzu Chi General Hospital
Enrollment
70
Locations
1
Primary Endpoint
the self-management level assessed by the self-developed scale
Status
Completed
Last Updated
2 years ago

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2019
End Date
December 31, 2020
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Dalin Tzu Chi General Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • being unwillingness to participant this work
  • Attending the similar health education program in the past

Outcomes

Primary Outcomes

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

Time Frame: up to six months

Secondary Outcomes

  • the self-care level assessed by the self-developed scale(up to six months)

Study Sites (1)

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