Conversation Map and Diabetes in Pakistan
Condition: Diabetes Mellitus; Diabetes; Self Efficacy; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Background Diabetes is recognized as an important cause of premature death and disability.
      Non-clinical interventions play an important role in the control of diabetes and the
      prevention of its associated complications. Traditional methods of educating diabetic
      patients to empower them for the control of their disease might not work in the developing
      world. However, the novel interactive and pictorial health education tool named Diabetes
      Conversation Map (DCM) might be effective for the improvement of diabetes management
      self-efficacy and distress among diabetic patients in lower middle income setting of Karachi,
      Pakistan.

      Objective To assess the effectiveness of DCM as compared to routine care to improve the
      diabetes management self-efficacy (DMSE) and diabetic distress (DD) among type 2 diabetic
      patients (T2DM) visiting diabetic clinics of tertiary care hospitals in lower middle income
      setting of Karachi, Pakistan.

      Methodology This will be a two arms randomized controlled trial, conducted in two tertiary
      care hospitals, Karachi. A sample of 120 T2DM patients of age 30 - 60 years with sub-optimal
      diabetes control will be screened through eligibility criteria and diabetes distress
      screening tool. Patients who fulfill the eligibility criteria and have diabetes distress will
      be randomized into intervention (n=60) and control group (n=60) using sealed envelopes. The
      intervention arm will receive four diabetic education sessions using the DCM in a group of
      5-8 participants and each session will be at the interval of one (1) week, by the principal
      investigator. T2DM patients in the controlled arm will receive routine care. Data on DMSE and
      DD will also be measured 2-3 months post intervention after the completion of all education
      sessions. Descriptive statistics will be used for data analysis through SPSS version 20;
      whereas, application of Repeated Measures ANOVA will be carried out for inferential
      statistics.
    

Detailed description: 
      Like any other chronic disease, the control of diabetes is very essential. Non-clinical
      interventions such as life style modification, stress relief and healthy dietary habits have
      been proven to be effective against the control of diabetes and prevention of diabetes
      related complications. Traditionally, diabetic patients used to receive education related to
      their disease process, metabolic control, exercise and diabetic diet through didactic
      lectures, brochures, pamphlets, and face to face counseling. While these traditional methods
      are found to be effective in diabetes self-management in the western world due to better
      literacy rate, level of understanding and access to modern modes of communications. However,
      in the developing world these methods could not work because of several reasons including
      poor literacy. Among novel methods, Diabetes Conversation Maps are considered as useful tools
      for the educational empowerment of diabetic patients. These are interactive pictorial tools
      designed in such a way that it does not need formal education for common understanding. In
      developing countries like Pakistan, where the literacy rate is very less, these tools might
      prove to be effective for the control of diabetes and its associated complications. Diabetes
      conversation maps have been used and tested in several countries predominantly in the
      developed world. In the developing region, while it has shown some impact during the
      observational studies, literature generated from randomized control trials is still limited.
      Patients in the developing region has different level of education and environmental
      exposures such as access to internet and social media, they have different socio-demographic
      characteristics and hence might behave differently from their counterparts in the developed
      world. Therefore, there is a need of well-designed randomized controlled trial to evaluate
      the effectiveness of Diabetes Conversation Map versus routine diabetic care in DMSE and DD in
      a low middle income setting of Karachi, Pakistan.

      Research Question Is effectiveness of DCM as an educational tool same as routing care for
      improving the DMSE and DD in patients with T2DM visiting diabetic clinic of a tertiary care
      hospital in Karachi, Pakistan? 1.2 Significance of study: This study is a pioneer effort for
      generating new knowledge about the use of Diabetes Conversation Map. Findings of this study
      will be helpful for the nursing leadership and organizational leadership for use of Diabetes
      Conversation Map for managing the risks factors / complications of the DM. Also, it is cost
      effective intervention to be implemented by the health professionals, resulting in saving
      patients from managing DM, its complications, money and time. Moreover, findings of this
      study will be available for Pakistan Nursing Council (PNC) and Pakistan Medical and Dental
      Council (PMDC), for inculcating it into the curricula.

      1.3 Hypothesis 1.3.1. H0: The effectiveness of DCM as educational tool is same to routine
      diabetic education among patients with diabetes type 2 (T2DM) visiting diabetic clinic in a
      tertiary care hospital of Karachi, Pakistan.

      1.3.2. Ha: The effectiveness of DCM as educational tool is different to routine diabetic
      education among patients with diabetes type 2 (T2DM) visiting diabetic clinic in a tertiary
      care hospital of Karachi, Pakistan.

      1.4 Objective of the study The objective of this study is to assess the effectiveness of DCM
      as an educational tool in comparison to routine care for improving the DMSE and DD among
      patients with type 2 diabetes mellitus visiting diabetic clinic of tertiary care hospital in
      Karachi, Pakistan.

      1.5 Operational definitions

      T2 Diabetes mellitus:

      Type 2 diabetes is a metabolic condition where body develops resistance for insulin by
      progressive beta-cell dysfunction.

      Diabetes control:

      Patients with type 2 diabetes mellitus having HbA1c≤7

      Diabetic Management Self-Efficacy (DMSE):

      Patient level of confidence and believe that they can perform diabetes management activities
      such as, eat control diet, monitoring of blood glucose, administration of insulin/timely
      intake of oral medication , medical checkup, daily exercise in routine life in spite of
      challenging circumstances.

      Suboptimal control of diabetes:

      HbA1c is a clinical indicator, which shows how well diabetes is controlled for the last 3
      months. HbA1c level more than 7 % will be considered suboptimal control of diabetes

      Diabetes distress (DD):

      Patient Experiences trouble and invisible emotional burdens, when managing a severe chronic
      disease like diabetes.

      METHODOLOGY 1.1 Study Design: Randomized controlled trial 1.2 Study setting: This study will
      be conducted in National Institute of Diabetes and Endocrinology (NIDE) Ojha campus Dow
      University of Health Sciences (DUHS).

      1.3 Study duration: Duration for the study will be one year after the final approval of
      synopsis. 1.4 Sample size A study from China (41) reported mean DDS score of control and
      intervention group at baseline as 32.77±14.57 and 26.08±9.92 respectively. After intervention
      the respective scores were 22.79±4.95 and 30.09±12.14. Using these estimates, 95% confidence
      interval and 80% power of the test, the computed sample size was 88, 44 in each group. After
      adding attrition rate, a total of 120 subjects i.e. 60 in control arm and 60 in intervention
      arm will be included in the study. Since there are two hospitals, 30 participants in each
      group will be included from each hospital.

      1.5 Sampling technique Individual randomization will be done by opening the sealed envelopes
      for the allocation of intervention. There will be 120 sealed opaque envelopes containing
      either diabetes conversation map (acronym DCM; n=60) or routine care (acronym RC; n=60).
      These envelopes will be shuffled and opened for each eligible participant.

      1.6 Data collection The principle investigator (PI) will take permission from related
      authority. The PI will be sitting in the waiting area outside the clinic where the physician
      will refer all the patients diagnosed with T2 diabetes with suboptimal management. After
      screening based on eligibility criteria, informed consent will be taken. Structured
      Questionnaire will be used for collecting demographic, clinical, and laboratory data.

      After 3 months of enrollment, a follow up interview will be conducted using a structured
      questionnaire and blood test for HbA1c to see the change in baseline measurements across the
      two groups.

      1.7 Intervention arm The intervention arm will receive 4 sessions based on diabetes
      conversation maps. These sessions will be conducted 1 week apart (45-60min) in a group of 5-8
      participants per group. These sessions will be facilitated by a trained educator. These
      sessions will include topics on managing diabetes, following a healthy lifestyle, starting
      insulin, and experiencing life with diabetes.

      Conversation Map (CM) education tools are a series of tools for facilitated group education
      5-8 that were developed by Healthy Interactions in collaboration with the International
      Diabetes Federation (IDF) and are sponsored by Lilly Diabetes.

      CM-based education guides people with diabetes through a process with the aim of helping them
      understand and internalize information about their disease and generate insightful
      conclusions, which may then result in improved self-management decisions and actions.

      1.8 Control Arm In control group, participants will attend their routine regular appointments
      to health care professional and receive instruction provided as part of routine care during
      the study period.

      1.9 Ethical concerns Approval for ethical consideration will be taken from Institutional
      Review Board of DUHS. Written inform Consent will be taken from all the participants
      including permission to access their medical records. No individual information of study
      participants and organization will be published as the data and results published will be in
      aggregate form for maintaining the confidentiality of the study participants and
      organization. All the information about the study participants will be kept in lock and key.

      1.10 Study Variables:

      Dependent variables:

      Diabetes Management Self-Efficacy (DMSE) and Diabetes Distress (DD) and HbA1c are dependent
      variable in this study.

      Independent variables:

      This will include age, gender, BMI, education level, occupation, marital status, time since
      diabetes diagnosis, time since diabetes treatment, type of treatment for Diabetes e.g.
      Tablets, insulin etc. use of smart phones, use of internet and monthly income.

      1.11 Statistical Analysis: All statistical analysis will be performed using SPSS version 20.
      Intention to treat and per protocol analysis will be performed. Descriptive statistics will
      be reported by computing frequencies and percentages for categorical variables and means,
      standard deviation and ranges (minimum and maximum) values for continuous variables. Outcome
      variables will be calculated by summing the scores of respective scales. Repeated Measures
      ANOVA will be used to measure difference in HbA1C, DMSE and DDS between intervention and
      control arm. Sensitivity analysis will be run to measure effect of any missing observations
      on outcome of the study.
    

Intervention name(s): Diabetic Conversation Map
Intervention type(s): Behavioral
Intervention description(s): Diabetic Conversation Map education tools are a series of tools for facilitated group education 5-8that were developed by Healthy Interactions in collaboration with the International Diabetes Federation (IDF) and are sponsored by Lilly Diabetes.
CM-based education guides people with diabetes through a process with the aim of helping them understand and internalize information about their disease and generate insightful conclusions, which may then result in improved self-management decisions and actions.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This will be a 2 arms individual randomized controlled trial. Intervention arm will receive teaching from the nurses using diabetic conversation map with visual images and control arm will receive teaching from the nurses using the traditional diabetic counselling.
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Diabetes; Type 2 Diabetes mellitus; Health Education; Conversation Map; Developing countries