Information, Networks and Rewards to Optimise Adherence to Diabetic Services
Condition: Diabetes
Study type: Interventional

Summary: 
      This prospective, randomised controlled trial is to investigate whether the complex
      intervention, including incentives (inexpensive cellphone top-ups), information (viewing
      one's own fundus photos and receiving SMS informational reminders) and peer support (Diabetes
      clubs), improve compliance with eye care among rural persons living with diabetes in southern
      China.
    

Detailed description: 
      Background: Diabetes affects some 10% of rural-dwellers in southern China. Demand for care of
      both diabetes and DR is low in this population: Only 25% are in care for diabetes (vs 100% of
      a matched urban cohort), 0% were being treated for DR (vs 55% of the urban cohort) and 31%
      said they were likely/very likely to accept diabetic eyecare when it was described to them
      (vs 78% of the urban group). A simple intervention of informational SMS reminders could
      significantly increase knowledge about DR and satisfaction with care among rural dwellers,
      while tripling their compliance with scheduled eye examinations. However, even in the group
      receiving the SMS reminders, over half failed to present for exams. More effective
      interventions are needed.

      Participants: All the participants with treated diabetes or HbA1c >=6.5% from the Guangdong
      (Yangjiang) centre of our population-based Rural Diabetic Eye Disease Survey. They must be
      aged 50-90 years, own a cell phone (ownership is > 95% in the area), have no mobility
      limitations precluding routine clinic visits or bilateral blindness (<6/120), and be capable
      of giving informed consent.

      Randomisation: To avoid contamination, we are clustering recruitment and randomisation at the
      level of village and inviting participants in the two study groups to the Yangjiang eye
      screening centre for follow-up on different clinic days. Block randomization, at village
      level, will be balanced by the distribution of education levels and travel times from
      screening centre.

      Intervention. All groups will be offered a brief video, already created and piloted,
      explaining basic information about diabetes and diabetic eye disease. The Intervention group
      will also receive (i) non-cash rewards (free eye care and modest mobile phone top ups in
      return for attendance at retinopathy screenings), the value of which will increase with the
      risk of vision loss (based on existing level of eye disease and HbA1c). (ii) Informational
      reminders delivered by SMS text 1 day and 1 week prior to scheduled eye exams. In keeping
      with health economic research,3 the reminders will emphasize anticipated regret: "Your next
      eye screening visit is next week, on dd/mm/yy. If you miss your eye screening visit, you
      might regret this if you subsequently lose your vision."; and (iii) peer and village health
      worker (VHW) networking (supported by the existing Orbis CREST project). Peer supporters will
      be a nominated family member or friend who has regular contact with the patient and a VHW or
      a community member with diabetes who has been trained to run monthly group educational
      sessions in the local village on optimum self-care and self-management of diabetes/DR. An
      important function of the family member or peer supporter is also to re-inforce the SMS
      informational reminders before the scheduled clinic visit.

      Primary outcome measure: Proportion of scheduled eye care visits attended over 1 year.
      Secondary outcomes, not the direct target of our intervention, but which might be improved by
      a behavioural spill-over effect, will include: follow-up HbA1c; medication adherence;
      retinopathy grade and visual acuity in the better seeing eye.

      Power and sample size: Assuming an effect size d= 0.44, and an attrition of 15% over two
      years, a full trial of 412 patients (42 villages in each of the two groups and 206 patients
      per group) would have 90% power (two sided alpha error 0.05).
    

Intervention name(s): cash rewards for the fellow up; Showing retinal photos to participants; SMS reminders for participants and their family; Watching brief video and basic explanation for disease; Having the Diabetic Club
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): This is a multiple stimulus intervention study, and there are two intervention groups. One is the normal intervention group, and the other is the adjusted intervention group. The intensity of intervention in the latter group is based on the severity of diabetic disease.; This is a multiple stimulus intervention study, and there are two intervention groups. One is the normal intervention group, and the other is the adjusted intervention group. The intensity of intervention in the latter group is based on the severity of diabetic disease.; This is a multiple stimulus intervention study, and there are two intervention groups. One is the normal intervention group, and the other is the adjusted intervention group. The intensity of intervention in the latter group is based on the severity of diabetic disease.; This basic explanation will be offered by professional doctors or nurses.; This is a multiple stimulus intervention study, and there are two intervention groups. One is the normal intervention group, and the other is the adjusted intervention group. The intensity of intervention in the latter group is based on the severity of diabetic disease.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Keywords: Diabetes; follow-up; Diabetic retinopathy; Diabetic teaching; SMS; rewards