Devi 2014.
| Methods |
Study design: Randomised controlled trial. Control group: Usual care. |
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| Participants |
Study location: UK CHD diagnosis/treatment: Primary care angina patients. Mean age (SD): Intervention group: 66.27 (8.35) Control group: 66.20 (10.06) Percentage men: Intervention group: 71% (n = 34) Control group: 78% (n = 36) All participants: 78% (n = 74) Number of participants recruited: 94 Participant ethnicity: White British 91%, other white background 5%, other 4%. Recruited online or offline? Participants recruited offline, from primary care; GP practices. |
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| Interventions |
Name of the intervention: ActivateYourHeart Intervention aim: To improve health behaviours related to CHD. Intervention features: The programme contained 4 stages; at each stage the user was set individualised goals focused on exercise, diet, emotions, and smoking. Compliance with these goals was checked at the end of each stage, and then goals were reset/modified accordingly. Participants uploaded data related to physical activity, emotions/mood, and smoking. Regular feedback on these behaviours was provided. The website also contained tailored information about the secondary prevention of CHD. How was the intervention introduced to the sample? The researcher provided face‐to‐face training on how to use the intervention, which involved registering the individual (creating a unique username and password), and demonstrating how to use the programme. Was there any contact between the researcher/healthcare professional and the sample during the intervention? A cardiac nurse was available for advice/support throughout the programme through either an online email link or by joining a scheduled synchronised chat room held on a weekly basis. Duration of the intervention? 6 weeks. |
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| Outcomes |
Outcomes: 1. Physical activity. Measurement tool: an accelerometer, SenseWear Pro 3 armband 2. Blood pressure 3. Fat and fibre intake. Measurement tool: Dietary Instrument for Nutrition Education (DINE) 4. HRQOL. Measurement tool: MacNew Time points: 6 weeks and 6 months. |
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| Notes | Trial was registered with the ISRCTN registry. Registration number: ISRCTN90110503 | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐generated randomisation |
| Allocation concealment (selection bias) | Low risk | Sealed envelopes |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | No blinding, and some of the outcomes may have been influenced by the lack of blinding |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | No blinding, and some of the outcomes may have been influenced by the lack of blinding |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Attrition rate was 23%, with number of dropouts balanced across groups, with similar reasons for missing data across groups |
| Selective reporting (reporting bias) | High risk | Not all the measures reported in the protocol have been reported: cost and level of positivity |