Pragmatic cluster randomized controlled trial with additional qualitative and quantitative process evaluations. The CONSORT statement on pragmatic trials was used to assist with the design .
Patients with Type 2 Diabetes attending 45 Community Health Centres in the Cape Town Metropole were the target population. Thirty eight health promoters are currently employed within these facilities.
Data from a previous study in the same population (n=450, 18 clinics) showed that the mean HbA1c was 8.8% (SD 3.3) and intraclass correlation 0.1 . Similarly the mean weight was 78.2Kg (SD 16.7) and intraclass correlation 0.05. These figures were used to calculate the sample and cluster size for a 5% weight reduction and a 1% reduction in HbA1c. Based on a level of significance of 0.05 and a power of 0.8 the study required 17 clusters in each arm with 40 patients per cluster. The total sample size therefore would be 34 clusters (health centres) and 1360 patients.
Sample selection process
Community health centres that agreed to participate were randomly allocated by computer generated random numbers to either control or intervention groups. All type 2 diabetic patients attending the selected health centre on the recruitment days were invited to participate in the study. Recruitment days were when the health centre had a diabetic club. Centres were visited weekly until the sample of 40 patients per health centre was obtained. Altogether 720 patients were recruited in the intervention arm and 850 in the control arm giving a total of 1570.
Inclusion and exclusion criteria
Inclusion: All type 2 diabetic patients who gave consent, regardless of the type of medication (oral and/or insulin) or time since diagnosis.
Exclusion: Type 1 diabetic patients, those who refused consent, those who were judged by the clinical nurse practitioner or medical officer as unable to participate in the intervention (for example due to acute illness, mental illness, dementia or another justifiable reason).
Design of intervention
The intervention was developed by the researchers with assistance from a diabetes nurse educator and social scientist with an interest in behaviour change counseling. The sessions were piloted with a group of diabetic patients attending Groote Schuur Tertiary Hospital.
The following overall structure was suggested by the chronic care teams (including health promoters) in a previous study . Patients should receive 4 educational sessions each lasting between 20–60 minutes. Sessions should be offered when the patients are scheduled for a routine visit to the health centre by a health promoter. Groups should have between 10 and 15 people who would remain together throughout the programme:
Session 1: Understanding diabetes
Session 2: Living a healthy lifestyle
Session 3: Understanding the medication
Session 4: Preventing complications
The researchers reviewed a number of materials for group education and found the Conversation Map™ the most congruent with the design of the intervention [23–25]. The Conversation Map™ materials were piloted in a rural town to see which aspects were appropriate for the local context . A number of the group activities, such as working with myths and facts cards, recommended in the Conversation Map™ material were adapted for the local context. The researchers also developed new graphic materials to help patients understand the patho-physiology of diabetes as well as the effect of medication and self-care activities. Pictures were developed to illustrate portion size and food choices. All these pictures were then designed and printed in the format of a flip chart. A comprehensive set of food cards illustrating local South African foods and which could be used in group activities were also purchased. Patient education materials on foot care, coping with stress, alcohol and smoking cessation were also developed or sourced locally.
The sessions were designed to be congruent with a guiding communication style . This style was intended to include the following characteristics:
Collaboration: Both health promoters and patients should contribute substantially to the group discussion
Empathy: Health promoters should demonstrate active listening skills and their understanding of the patient’s perspective, particularly through the use of summaries.
Support for autonomy: Health promoters should promote a sense of choice and control over behaviour change
Evocation: Health promoters should elicit change talk and possible solutions from the group members
Direction: Health promoters should manage time and keep aligned with the intended content and purpose of the sessions
It was also recognized that diabetes education often involves a significant component of information and therefore strategies to exchange information rather than just transfer it were taught. In particular the use of elicit-provide-elicit was emphasized as a strategy and in fact the sessions themselves were structured according to this model. This model involves the following three steps in a cyclical process .
Elicit either the groups prior knowledge or what they are most interested in learning about with regard to a specific topic
Provide the group with information in a neutral way that builds on what they already know or addresses what they are most interested in
Elicit how group members will make sense of or apply this information personally
The researchers recognized that health promoters were used to delivering health education in a directing style, often in quite difficult circumstances. This directing style was characterized by an authoritarian, expert role that told patients what they should be doing. Educational talks were often given to the whole reception area where health promoters had to shout over staff and patients waiting to be seen. The educational model developed in this study was therefore quite a shift from what health promoters were used to. The goals therefore in terms of communication skills were kept as simple as possible. The training manual with more detailed information on the sessions is available as a Additional file 1.
The control patients received usual education at the health centre. Usual education consisted of ad hoc educational talks in the reception area or club room as well as any individual counseling that providers might have time for in the consultation.
Training of health promoters
Health promoters were trained in an initial 4 day workshop which focused on the overall structure of the sessions, communication style and skills, diabetes knowledge and the first two sessions. Training was conducted in a similar small group educational process with the trainers modeling the same skills expected of the health promoters when they educated patients. Following the initial workshop health promoters began the education immediately and a further 2-day workshop was held 2 months later to reinforce the initial training and introduce the last 2 sessions. The researcher who evaluated their fidelity to the intervention visited each health centre at least twice and gave some feedback to the health promoters after the sessions.
Implementation of intervention
At the end of the HPO’s initial training a number of logistical issues were addressed. These included identifying the room where sessions could take place or if no space was available in the health centre a suitable local venue such as a library or community hall. Of the 17 randomly selected health centres only 13 had health promoters currently employed and therefore 4 of the health promoters agreed to offer the intervention at two sites.
Following recruitment the patients at each health centre were grouped to time the educational sessions on the same date as their routine attendance for medication. Patients were sent bulk SMS reminders of the date and time of their educational sessions and health promoters were encouraged to call the patients prior to the meetings to remind and motivate them. A once off shopping voucher for a local supermarket was offered as an incentive to attend the sessions (this was equivalent to $2). Letters were sent to all those without a phone and to the pharmacist asking for medication to be handed out at or after the educational session. Attendance certificates were available for those who were working. Health promoters were also provided with glucometers so they could test patient’s glucose at the sessions in the hope that this would also encourage attendance.
Data collection process
Data was collected at baseline and 12 months later. Data collection teams were employed to visit the health centres over a period of 4 weeks and consisted of a nurse and field workers. Nurses were employed to collect blood and take physical measurements and all members completed the questionnaires with patients. Standard operating procedures were used in measuring weight (electronic scales), waist circumference (tape measure) and blood pressure (Omron digital blood pressure monitor). HbA1c and total cholesterol were measured by one laboratory under the National Health Laboratory Service where quality control measures were in place. The data collection teams received a 1-day training workshop prior to the data collection periods and were supervised daily by the project co-ordinator.
It was not possible to blind the health promoters, patients or data collection teams as to whether the health centre was a control or intervention site.
Data collection tools
The following data was collected from participants and their medical records at baseline: Age, sex, duration of diabetes, medication used and medical history for concomitant diagnoses and complications. Medication use and new diagnoses were also recorded at follow up.
Self-care activities were measured using a questionnaire that separately scores diet, exercise, foot care, smoking and medication use. This validated questionnaire had previously been used successfully in the South African context .
Locus of control measures the patient’s belief in their ability to control their illness (internal locus of control) as opposed to a belief that their illness is outside their own control and primarily in the hands of others (external locus of control) or that control is a matter of luck (chance locus of control). Group education using a patient-centred approach has been shown to increase ones internal locus of control, which itself is linked to the likelihood of behaviour change. A specific questionnaire that measures diabetic locus of control has been developed and was used in this study .
Self-efficacy is a measure of the patient’s actual confidence in their ability to perform self-care activities. A simple measure of diabetic self-efficacy has been developed by Stanford University’s study on Diabetes Self-Management . Enhancing self-efficacy is one of the key principles of motivational interviewing and is linked to the likelihood of actual behaviour change . The Stanford questionnaire was contextualized and used to measure self-efficacy.
Diabetes quality of care was measured using a questionnaire that has previously been used in the South African context for Type 2 Diabetic patients . Quality of life is an important health outcome that may be impacted by psychosocial factors, complications, duration of diabetes, demographic variables, gender, type of diabetes, glycaemic control and treatment regimes .
Fidelity to the planned educational programme and to the communication style was assessed by observing 36 randomly selected group sessions. Sessions were stratified to ensure that each site and session was sampled equally. The observer noted the extent to which the session followed the intended content and process and also made additional field notes. Sessions were recorded on audiotape and subsequently evaluated using the Motivational Interviewing Treatment Integrity Coding, which is a validated tool for assessing proficiency in MI . This tool determines whether the counselor achieved beginning proficiency in MI.
The health promoters experience was evaluated by means of three focus group interviews that were facilitated by an independent researcher. The initial focus group was held immediately after the training, the second was held mid-intervention and the third after all the education had been completed. The patient’s experience was evaluated by means of in depth interviews with one patient from each of the health centres in the intervention group who had attended at least 3 of the sessions. Interviews were also conducted by an independent researcher in the patient’s home after the educational sessions were completed. The qualitative data from these interviews was transcribed verbatim and analysed using the framework method and Atlas-ti software.
Intention-to-treat analysis will evaluate the primary and secondary outcomes. Any missing baseline data will be imputed using the Markov chain Monte Carlo approach. Missing status at follow-up will be modelled on baseline covariates and randomised group using logistic regression. Inverse probability weighting will be used for the final trial analysis. Models for comparing continuous outcomes will use linear regression and for categorical outcomes will use logistic regression with adjustment for baseline covariates and clustering.
Baseline data collection took place in September-December 2010. The intervention was delivered between October 2010 and April 2011. Follow up data collection took place in September-December 2011. Data capture and cleaning were completed by February 2012 and we are now busy with data analysis.