Wolever 2010.

Methods	Randomized controlled trial
Participants	The study location was Duke University Medical Center, Durham, North Carolina, USA 30 participants were randomized to the intervention group and 26 participants were randomized to the control group The inclusion criteria were English speaking, at least 18 years of age, have a diagnosis of type 2 diabetes for at least 1 year, be taking oral diabetes medication for at least 1 year, and have medical and pharmacy benefits available to the study team The exclusion criteria were dementia, Alzheimer disease, schizophrenia, or other cognitive impairment that would preclude informed consent
Interventions	Intervention: INTEGRATIVE HEALTH (IH) COACHING 2 coaches provided the coaching intervention. Both had substantial training in coaching methods as well as masters‐level degrees in social work or psychology. Coaches each had over 100 hours of experience of individualized coaching with type 2 diabetes patients and had previously facilitated diabetes coaching groups. Participants randomized to the coaching condition had an initial telephone session with their coach within 2 weeks of the baseline visit. They were then offered 30‐minute coaching sessions by telephone (8 weekly calls, 4 biweekly calls, and a final call 1 month later) for a total of 14 sessions. Participants were paired with the same coach throughout the intervention. During the initial telephone call, participants were asked what was important to them in terms of diabetes care, how well they were managing their health, and what they perceived to be their challenges or areas of required support. Patients were guided in creating a vision of health, and long‐term goals were discussed that aligned with that vision. To facilitate learning, participants randomized to IH coaching received a binder of educational materials at the initial assessment visit. Contents included materials from GlaxoSmithKline's Adherence Starts with Knowledge® (ASK‐20) and Essential Connections® as well as information from Duke Integrative Medicine. These were referenced throughout the interactions of the study. The ASK‐20 is a brief survey that helps practitioners quickly identify and target reasons patients may not be adhering to prescribed medication regimens. It is accompanied by materials on topics relevant to self management such as symptom recognition, self care, and disease risk factors. Duke Integrative Medicine provided information regarding nutrition, stress management, and tips on how to best utilize time with the coach. Additional materials came from Essential Connections, a resource of tools for coaches to facilitate motivational interviewing techniques and behavior change, linking topics of interest with patients' readiness to change and relevant education content Control: USUAL CARE Control group participants received usual care, with no additional materials or correspondence
Outcomes	The measures of adherence were self reported Morisky Adherence Scale. This questionnaire was administered at baseline and after 6 months by blinded staff The patient outcomes were A1C, perceived stress, and quality of life. Measures were collected by blinded study staff at baseline and again after the 6‐month intervention. Perceived stress was measured by the PSS‐4 scale (self report) and quality of life by the Shot‐Form Health Survey (SF‐12)
Notes	―
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Randomization was not described in detail. "Procedure and randomization at the baseline visit, participants provided informed consent; filled out demographic, medical history, and psychosocial questionnaires; reported current medications; and had blood drawn." (pg 631)
Allocation concealment (selection bias)	Unclear risk	No information was provided about how allocation was handled
Selective reporting (reporting bias)	Unclear risk	No protocol available; although it appears that everything was reported it is difficult to determine this without a protocol
Other bias	Low risk	The study seems to be free of other types of bias.
Blinding of outcome assessment (detection bias) Adherence measure	Low risk	(PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ "Preassessments and postassessments were administered by blinded study staff." (pg 631)
Blinding of outcome assessment (detection bias) Patient outcome	Low risk	(PRIMARY) A1C ‐ This is an objective outcome and "Preassessments and postassessments were administered by blinded study staff." (pg 632)
Blinding of participants (performance bias) Adherence measure	High risk	(PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ This is a subjective measure; there is no information on blinding
Blinding of participants (performance bias) Patient outcome	Low risk	(PRIMARY) A1C ‐ This is an objective measure of outcome
Blinding of personnel (performance bias) Adherence measure	Unclear risk	(PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ No information on blinding given. There is insufficient information to permit judgment of 'Low risk' or 'High risk'
Blinding of personnel (performance bias) Patient outcome	Low risk	(PRIMARY) A1C ‐ This is an objective measure of outcome
Incomplete outcome data (attrition bias) Adherence measure	Low risk	(PRIMARY) SELF REPORT ‐ QUESTIONNAIRE ‐ There was a small number of dropouts, evenly spread across the groups
Incomplete outcome data (attrition bias) Patient outcome	Low risk	(PRIMARY) A1C ‐ There are few dropouts, evenly spread across the conditions