Cohen 2011.
| Study characteristics | ||
| Methods |
Aim of study: to assess whether Veterans Affairs Multi‐disciplinary Education and Diabetes Intervention for Cardiac Risk Reduction Extended for 6 Months could improve attainment of target goals for hypertension, hyperglycaemia, hyperlipidaemia, and tobacco use in patients with type 2 diabetes compared to primary care after 6 months of intervention Study design: RCT (1:1 randomisation; unit of allocation: individual) Number of arms/groups: 2 |
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| Participants |
Description: patient/consumer Geographic location: USA Setting: medical centre (Veterans Affairs medical centre) Inclusion criteria: veterans with type 2 diabetes HbA1c > 7%, LDL‐C > 100 mg/dL; coronary artery disease LDL > 70 mg/dL, BP > 130/80 in previous 6 months Exclusion criteria: gestational diabetes, unable to attend group sessions, psychiatric instability or organic brain injury that precluded diabetes self‐care Number of participants randomised: 103 Number of participants included in analysis: 99 (50 and 49) Age: mean ± SD I: 69.8 ± 10.7, C: 67.2 ± 9.4 Gender: female: 0% (n = 0) vs 4% (n = 2) Ethnicity: not specified Number of medications: total not available (added means = 4.20 vs 4.15). Hypertension: 2.02 ± 1.09 vs 1.86 vs 1.12, diabetes: 1.38 ± 0.81 vs 1.47 ± 0.82, cholesterol: 0.80 ± 0.49 vs 0.82 vs 0.53 Frailty/Functional impairment: not specified Cognitive impairment: not specified Comorbidities: heart failure 16% vs 10.2%, smoker 14% vs 8.2%, stroke 4% vs 4.1%, coronary heart disease 48% vs 46.9%, COPD 14% vs 20.4%, mood disorder 14% vs 14.3% |
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| Interventions |
Group 1 ‐ VA MEDIC‐E: 4 weekly group sessions followed by 5 monthly booster group sessions. Each 2‐hour session included 1 hour multi‐disciplinary diabetes‐specific healthy lifestyle education and 1 hour pharmacotherapeutic intervention performed by a clinical pharmacist (diabetes educator). Family/friends encouraged to participate. 90‐minute booster sessions were less structured Group 2 ‐ Usual care (clinic visits with primary care providers; average once every 4 months) Co‐intervention: N/A Provider: weekly multi‐disciplinary (pharmacist, dietician, pharmacist/PT, nurse) + monthly booster clinical pharmacist Where: medical centre room When and how often: 4 once‐weekly + 5 monthly boosters Intervention personalised: sessions were group based; however pharmacist sessions were more informal and allowed for open discussion about each individual's risk factor control, obstacles, solutions |
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| Outcomes |
Timing of outcome assessment: baseline and 6 months Medication adherence (objective): medication possession ratios: total days supply of medication received divided by total number of expected medication intake days Health‐related quality of life (subjective): change in VR‐36 (SF‐36 for veterans) Condition‐specific outcomes (objective): achievement of glycaemic and cardiac risk factor goals. Percentage of participants achieving SBP < 130, LDL < 100, A1c < 7% |
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| Notes | Trial registration: NCT00409240 Consumer involvement: not specified Funding source: Sandra A. Daugherty Foundation Dropout: 4 before intervention, 3 died Further information required: total number of medications and complete data regarding medication adherence (email correspondence with trial author ‐ successful, but authors had no further data available) |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Assigned in a 1:1 ratio; no details on randomisation method |
| Allocation concealment (selection bias) | Unclear risk | No details on allocation specified |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Unable to blind participants/personnel; assumed intervention would impact behaviour |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No mention of blinding |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 103 randomised, 99 included in analysis; 4 revoked consent (3 vs 1); 3.8% attrition |
| Selective reporting (reporting bias) | High risk | Raw data missing for adherence. MPR for total medications quoted but total number of medications not reported |
| Other bias | Low risk | None noted |