Vernooij 2012.
Methods |
Study design: Randomised controlled trial. Control group: Usual care, participants were asked to contact their physician (vascular surgeon, cardiologist, neurologist) at the hospital or the general practitioner for risk factor management. The treating physician was then free to determine the frequency of control. |
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Participants |
Study location: Netherlands. CHD diagnosis/treatment: All participants had been diagnosed with a manifestation of vascular disease, coronary artery disease (46%), cerebrovascular disease (27%), abdominal aortic aneurysm (4%), and peripheral vascular disease (23%). Mean age (SD): Intervention group: 60.7 (7.8) Usual care group: 59.2 (8.9) Percentage men: Intervention group: 78% (n = 128) Control group: 71% (n = 118) All participants: 74.55% (n = 246) Number of participants recruited: 330 Participant ethnicity: This information is not provided. Recruited online or offline? Offline, participants were recruited through referral from a vascular specialist/GP. |
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Interventions |
Name of the intervention: No name. Intervention aim: Manage vascular risk factors in people with clinically manifest vascular disease. Intervention features: The website was personalised for each participant. CHD risk factors were displayed on separate web pages, and described a history of risk factor measurements (e.g. blood pressure, cholesterol), drug use, treatment goal, advice from the nurse, correspondence between the nurse and participant, and news items for that particular risk factor. How was the intervention introduced to the sample? There was a face‐to‐face introduction to the programme, participants were invited for an hour visit to the clinic where the participant received information on their risk factor levels, instructions on how to use the programme, and a username/password for access to the website. Was there any contact between the researcher/healthcare professional and the sample during the intervention? There was contact between the participant and the nurse practitioner through the website. In a case of non‐response, the nurse practitioner would contact the participant. Duration of the intervention? 1 year. |
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Outcomes |
Outcomes: 1. Cardiovascular events. 2. Total cholesterol. 3. HDL cholesterol. 4. LDL cholesterol. 5. Triglycerides. 6. Blood pressure. Time points: Baseline and 12‐month follow‐up (postintervention). |
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Notes | Trial was registered with ClinicalTrials.gov. Registration number: NCT00785031 | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Web‐based randomisation |
Allocation concealment (selection bias) | Unclear risk | Method of allocation concealment not described |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | No blinding, however the study outcomes are not likely to be influenced by the lack of blinding |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcome assessor was blinded to group assignment |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Low attrition rate (5%), reasons for drop‐out are not provided, however this small drop‐out rate is unlikely to have a major influence on the results in this study |
Selective reporting (reporting bias) | High risk | Not all the measures reported in the protocol have been reported: additional costs per additional patient achieving treatment goal, and cost per life year gained |