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. 2023 May 31;2023(5):CD014513. doi: 10.1002/14651858.CD014513

Quinn 2011.

Study characteristics
Methods Cluster‐randomized trial of a mobile phone personalized behavioral intervention for blood glucose control
Cluster‐RCT (26 clusters with 39 providers), conducted in primary care practices in 4 distinct Maryland areas, USA
Four arms: 1. Usual care (control arm), 2. Coach only (intervention arm 1), 3. Coach‐PCP portal (intervention arm 2) and 4. Coach‐PCP portal with decision support (intervention arm 3)
Participants Control arm N: 62
Intervention arm 1 N: 38
Intervention arm 2 N: 33
Intervention arm 3 N: 80
Diabetes type: type 2
Mean age: NR ± NR
% Male: NR
Longest follow‐up: 12 months
Interventions Control arm:
1) Clinician education
2) Promotion of self‐management
Intervention arm 1:
1) Case management
2) Electronic patient registry
3) Clinician education
4) Facilitated relay of clinical information
5) Patient education
6) Promotion of self‐management
7) Patient reminders
Intervention arm 2:
1) Case management
2) Electronic patient registry
3) Clinician education
4) Facilitated relay of clinical information
5) Patient education
6) Promotion of self‐management
7) Patient reminders
Intervention arm 3:
1) Case management
2) Electronic patient registry
3) Clinician education
4) Clinician reminders
5) Facilitated relay of clinical information
6) Patient education
7) Promotion of self‐management
8) Patient reminders
Outcomes 1) HbA1c, mean % (SD)
Control arm: pre 9.2 (1.7), post 8.5 (1.8)
Intervention arm 1: pre 9.3 (1.8), post 7.7 (1.0)
Intervention arm 2: pre 9.0 (1.8), post 7.9 (1.4)
Intervention arm 3: pre 9.9 (2.1), post 7.9 (1.7)
2) SBP, mean mmHg (SD)
Control arm: pre 130.0 (22.0), post 133.0 (20.0)
Intervention arm 1: pre 130.0 (18.0), post 134.0 (25.0)
Intervention arm 2: pre 133.0 (14.0), post 134.0 (16.0)
Intervention arm 3: pre 130.0 (14.0), post 128.0 (19.0)
3) DBP, mean mmHg (SD)
Control arm: pre 78.0 (12.0), post 79.0 (13.0)
Intervention arm 1: pre 79.0 (11.0), post 82.0 (11.0)
Intervention arm 2: pre 79.0 (9.0), post 78.0 (9.0)
Intervention arm 3: pre 79.0 (9.0), post 78.0 (10.0)
4) LDL, mean mg/dL (SD)
Control arm: pre 102.0 (36.0), post 91.0 (34.0)
Intervention arm 1: pre 103.0 (29.0), post 94.0 (32.0)
Intervention arm 2: pre 103.0 (33.0), post 94.0 (47.0)
Intervention arm 3: pre 106.0 (33.0), post 102.0 (32.0)
5) Harms (adverse events: hypoglycaemia, hospitalisations, ED visits, deaths), N (%)
Control arm: pre 0 (0), post 0 (0)
Intervention arm 1: pre 0 (0), post 0 (0)
Intervention arm 2: pre 0 (0), post 0 (0)
Intervention arm 3: pre 0 (0), post 0 (0)
Funding source This research project is funded through a contract between the University of Maryland Baltimore and WellDoc in addition to contributions by WellDoc, CareFirst Blue Cross/Blue Shield of Maryland, LifeScan, and Sprint. Additional funding was provided by the Maryland Industrial Partnerships program through the University of Maryland, an initiative of the A. James Clark School of Engineering’s Maryland Technology Enterprise Institute.
Notes —
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "…using a computer‐generated list of random numbers".
Allocation concealment (selection bias) Low risk Cluster.
Provider's baseline characteristics (selection bias) Unclear risk Not provided.
Patient's baseline characteristics (selection bias) Unclear risk In text, but not in table.
Patient's baseline outcomes (selection bias) High risk Quote: HbA1c (n4 ‐ 9.9% vs n1 ‐ 9.2%), P = 0.04.
Incomplete outcome data (attrition bias) High risk Although the authors state that "participant data were analyzed according to physician practices", original randomisation treatment assignment.
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) Low risk Primary: HbA1c, using medical charts, using Bayer DCA 200.
Secondary: SBP, lipids, obtained from charts.
Quote: "Patients and providers were not blinded, but outcome assessors were. HbA1c measured using the same A1c test device by trained staff who are blind to patient group assignment." From protocol.
Selective reporting (reporting bias) Low risk Checked protocol and everything matches.
Risk of contamination (other bias) Low risk Cluster.
Other bias Low risk Information not available.