Carter 2011.

Methods	Parallel randomised controlled clinical trial (RCT) Randomisation ratio: approx 1:1 Superiority design
Participants	Inclusion criteria: Dagnosis of type 2 diabetes Age 18 years or older Residing in the target area (Washington DC) Having a primary care physician willing to participate in the project or being willing to be assigned to a participating primary care physician in the community African American Ability to read at an eighth grade level or higher Exclusion criteria: Non–African American No diagnosis of type 2 diabetes Illiteracy or inability to read at an eighth grade level Visually or hearing impaired Non‐English speaking Dialysis required (excluded because disease is too far advanced for patients to benefit from the proposed diabetes self‐management programme) Reliance on psychotropic medication (excluded because mental illness could lead to behavioural issues relative to treatment adherence that are beyond the scope of the proposed diabetes self‐management programme Diagnostic criteria: Participants had to have been diagnosed with type 2 diabetes at least 2 years before the start of the study based on a positive reading of any of the following 3 tests, followed by a second positive test on a different day: Fasting plasma glucose equal to or greater than 126 mg/dL with symptoms of diabetes Casual plasma glucose (taken at any time of the day) equal to or greater than 200 mg/dL with symptoms of diabetes Oral glucose tolerance test (OGTT) value equal to or greater than 200 mg/dL, measured at a 2‐hour interval. OGTT is given over a 3‐hour time span
Interventions	Number of study centres: 1 Treatment before study: N/A Intervention: provider‐assisted, participant self‐management intervention with multiple aspects to it All participants in the intervention group were provided with a laptop equipped with a wireless scale, a blood pressure cuff and a glucometer (to measure weight, BP and glucose). Weight and BP were advised to be checked weekly, and blood glucose to be checked 3× a day Participants also had access to an online portal, which included 3 modules: A self‐management module This held the participant's health record and included a culturally competent action plan for management. Participants had a half hour video conference with a nurse every 2 weeks. In these conferences, the nurse reviewed the participant's recently uploaded biometric data and then discussed these data with the participant. The nurse went over necessary behaviour change strategies, discussed problems with the participant and provided guidance based on the participant's data and verbal feedback. The nurse then updated and transmitted a summary of the participant's health record data to the electronic health record that was accessible to the participant's provider A health education module This provided age‐appropriate and culturally appropriate health education videos, links to health education web sites and materials on nutrition, physical activity, etc. This was regularly updated by the research team A social networking module This linked all participants, so they could exchange coping strategies, pose questions, etc. Control: did not have access to the online portal, received standard care only
Outcomes	Outcomes reported in abstract of publication: Primary outcomes: HbA1c Blood pressure (mean, systolic and diastolic not given separately) BMI Secondary outcome(s): Weight (pounds) Diabetes knowledge (not clear what test was used to assess this) Diabetes management practices scale (not clear what test was used to assess this) Healthy eating scale (not clear what test was used to assess this) Physical activity scale (not clear what test was used to assess this) Self‐percieved physical health status (not clear what test was used to assess this) Self‐perceived mental health status (not clear what test was used to assess this)
Study details	Run‐in period: unclear Study terminated before regular end: no
Publication details	Language of publication: English Funding: National Center on Minority Health Disparities (NCMHD) research to reduce ethnic disparities in ESRD Export Grant Publication status: peer review journal
Stated aim of study	Quote from publication: "To see if a provider‐assisted, patient self‐management telehealth intervention could create access to quality monitoring for the medically underserved and lead to improve patient outcomes (HbA1C, BMI, BP)"
Notes	—
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Comment: random number table used
Allocation concealment (selection bias)	Unclear risk	Comment: unclear
Blinding of participants and personnel (performance bias) Objective outcomes	High risk	Comment: not blinded
Blinding of participants and personnel (performance bias) Subjective outcomes	High risk	Comment: not blinded
Blinding of outcome assessment (detection bias) Lab tests: Lipids, HBA1C	Unclear risk	Quote from publication: "We collected baseline data and then readministered the survey" Comment: not blinded
Blinding of outcome assessment (detection bias) Subjective outcomes	High risk	Comment: participants not blinded. Self‐reported measures
Incomplete outcome data (attrition bias) Objective outcomes	High risk	Comment: high rate of attrition—27 participants "lost to attrition." No discussion of why or for what reason. Sounds as though these 27 participants were randomly assigned but excluded from analysis. Therefore, appears to be a per‐protocol analysis, not ITT
Incomplete outcome data (attrition bias) Subjective outcomes	Unclear risk	Comment: unclear
Selective reporting (reporting bias)	Low risk	Comment: All outcomes stated are reported
Other bias	Unclear risk	Comment: none