Diabetic Self-care Education at Primary Health Care in Saudi Arabia: A Pragmatic Randomized Trial in Tabuk
Condition: Self-care; Preventive Care; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Diabetes Self-care Education (DSCE) is a formal term used to describe the ongoing process of
      facilitating the knowledge, skills, and ability necessary for diabetes self-care.

      Supporting self-care is a crucial aspect of any health service, especially the one that
      targeting diabetes. It has shown a positive effect on the clinical, psychological, and
      behavioural aspects of diabetics. However, culturally adapted educational services that
      recognize the context should be established and used carefully, as most of the social media
      and YouTube educational products are not relevant most of the time.

      Diabetic patients who receive no education about their diabetes, are four times as likely to
      develop complications as those who do not. Oppositely, those who attending diabetes education
      programs are less likely to develop long-term complications.

      The core question of the trial is to find an answer to the question: how the Diabetes
      self-care information, education provided by trained health care educator at primary care is
      effective in controlling patterns of blood glucose, reducing BMI, and enhancing self-care
      behaviour among diabetic patients attending chronic care clinic compared to the control group
      receiving routine care for diabetes.
    

Detailed description: 
      A pragmatic Trial is a modern approach for testing research hypotheses in real life to draw
      inspiration from the implemented intervention to inform decision making and change in health
      policy at the level of primary health care and the community.

      The trial outcomes could be used in making new policy that directly contributes to the model
      of care, health economics, and population health management program. It is a 12 months
      pragmatic randomized trial that will recruit type II diabetic patients attending primary
      health care centres in Tabuk city.

      Conclusion:

      Upon successful completion of the trial, the primary and secondary outcomes of the trial like
      reduction in the blood glucose level, Body Mass Index (BMI), waist circumference, HbA1c,
      serum cholesterol level, and blood pressure are expected. Besides, the development of new
      recommendations for diabetes self-care policy, model of care, and on-the-job training at
      primary health care.

      Sample size calculation:

      A sample of 250 participants for the two trial arms with an average cluster sample (m) of
      about 35 participants per cluster is calculated using STATA clustersampsi command. This is by
      specifying the total number of clusters (k) = 6, the mean for sample1 as (mu1) = 0.6, the
      mean for sample2 (mu2) = 0.31, the intra-class correlation coefficient (rho) = 0.01, at the
      power beta (0.8), and significant alpha level of (0.05).

      Data analysis:

      The collected baseline data and end-line data will be initially analyzed by carrying out both
      univariate and bivariate analyses. The univariate analysis will summarize data as means,
      standard deviations while multivariate analysis will yield correlations between the measured
      variables. Standard statistical tests such as the Student t-test, ANOVA, and F statistic will
      be used to test for the effects of interventions and to facilitate comparisons between
      intervention and control groups. Then the data will be further analyzed using multilevel
      models/hierarchical linear modelling as it allows adjustment of the effect of an intervention
      for (imbalance on) individual-level and cluster-level baseline predictors of outcomes. The
      collected data will be analyzed based on the intention to treat evaluate the primary outcomes
      among both the intervention and control groups i.e. the participants will remain in the group
      to which they were randomized. Linear regression models will be used for comparing the
      continuous variables. The BMI as a primary outcome will be analyzed using a linear regression
      model to find out the effects of the intervention among the intervention groups as well as
      among the control groups. The secondary outcomes include reduction in blood glucose level,
      serum cholesterol level, blood pressure, and waist circumference will be analyzed using
      linear regression models. Statistical significance will be set at 5%.

      Missing data will be managed by applying appropriate multiple imputation STAT commands. As
      the variables are continuous; Markov Chain Monte Carlo (MCMC) method will manage the missing
      data; it is planned to use SOLA software for managing data (available at
      http://www.solasmissingdata.com/software.

      Generalizability:

      This trial is expected to draw some more convenient findings that match the context in Saudi
      Arabia and other gulf regions. Given the great similarities in sociodemographic, and cultural
      aspect in addition to the similarities in a health care setting in the whole Kingdom. It is
      expected that a successful result could fairly be generalized to other health care settings
      in Saudi Arabia and even to other gulf regions.

      Expected limitation:

      The quality of data collection is expected to be not to the expected level. This is because
      the same health provider who will conduct the trial intervention is supposed to carry the
      data collection task. After all, the physical environment in the health care setting doesn't
      permit bringing additional staff to complete the task.

      Ethical considerations:

      Ethical approval will be obtained from the Institutional Review Board in the Faculty of
      medicine at the University of Tabuk and the Research Ethics Committee at the Ministry of
      health in Tabuk.

      Informed consent: The investigator will make sure that written informed consent is obtained
      from each participant before randomization and before the participant has undergone any study
      intervention or data collection procedures. The informed consent will be obtained by the
      primary health care physician in a special room at the health centre. The primary health care
      physician will provide the information about the trial and as well ensure that the
      participant has understood the information. This can be achieved through answering adequately
      the questions raised by participants; hence, the participants are encouraged to ask questions
      about the trial and will be given adequate time to decide, voluntarily, either to participate
      in the trial or not. If a participant needs more to decide, then the primary health care
      physician should give another appointment for the participants
    

Intervention name(s): Diabetic care Information, education, and communication intervention will be delivered by relevant and trained health animators working in chronic care clinic.
Intervention type(s): Behavioral
Intervention description(s): The training sessions and the IEC materials were adapted from John Hopkins University studies on self-care for diabetic patients.
Other intervention name(s): Self-care progression card and pictorial IEC messages were prepared and given to the patients or co-family members.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a 12 months randomized clustered trial that recruited individuals with type II diabetes mellitus attending primary health care clinics in Tabuk city, Saudi Arabia.
Health centres will be divided into two groups( intervention& control) using Random Number Generator.
Masking: None (Open Label)
Primary purpose: Prevention