Falces 2008.
| Methods | Randomized controlled trial | |
| Participants | The study location was a cardiology clinic, Hospital General de Vic, Osona, Barcelona, Spain 53 participants were randomized to the intervention group and 50 participants were randomized to the control group The inclusion criteria were over 70 years and hospitalized at the General de Vic hospital. The Framingham criteria were employed; 2 major criteria or 1 major and 2 minor criteria had to be present The exclusion criteria were residence outside the hospital area bounds, nursing home residence, waiting on surgery, another center, dementia or psychological instability, or refusal to participate |
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| Interventions | Intervention: EDUCATIONAL INTERVENTION
A research team pharmacist carried out the intervention. It consisted of an interview at hospital release followed by telephone reinforcement. The intervention focused on information about the disorder, diet education, and information about the medication. Simple language adapted to the cultural needs of the patient was used. This was backed up by audiovisual and written material. Phone calls took place during the first 6 months and for 2 months following. Patient questions or issues we also discussed. Patients were also given a contact phone number which they could call if they had doubts about their treatment or illness Control: CONTROL GROUP Visits were done at 6 and 12 months. A cardiologist provided treatment as usual and a pharmacist did a pill count |
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| Outcomes | The measures of adherence were pill count ‐ a pharmacist did a pill count at 6 and 12 months. He/she then categorized patients as 1) adherent if the patient had taken 95% to 100% of prescribed dose; 2) partially adherent (85% to 95% of dose taken); 3) not adherent if < 85% of dose taken The patient outcomes were 1) Time to rehospitalization, 2) percentage and 3) total number of patients rehospitalized, 4) total number of days in the hospital during the study period. Also 5) quality of life and 6) mortality during the follow‐up period |
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| Notes | ― | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Software‐assisted block randomization was used |
| Allocation concealment (selection bias) | Low risk | Allocation was handled by an admissions service |
| Selective reporting (reporting bias) | Unclear risk | None noted but protocol not available |
| Other bias | Unclear risk | Insufficient information to assess whether an important risk of bias exists |
| Blinding of outcome assessment (detection bias) Adherence measure | High risk | (PRIMARY) PILL COUNT ‐ Open study |
| Blinding of outcome assessment (detection bias) Patient outcome | High risk | (PRIMARY) QUALITY OF LIFE (QLS) ‐ Open study; subjective measure |
| Blinding of participants (performance bias) Adherence measure | High risk | (PRIMARY) PILL COUNT ‐ Open study. Does not mention if the pill count was done unbeknownst to patient |
| Blinding of participants (performance bias) Patient outcome | High risk | (PRIMARY) QUALITY OF LIFE (QLS) ‐ Open study; subjective measure |
| Blinding of personnel (performance bias) Adherence measure | Low risk | (PRIMARY) PILL COUNT ‐ Outcome not likely to be affected by key study personnel |
| Blinding of personnel (performance bias) Patient outcome | High risk | (PRIMARY) QUALITY OF LIFE (QLS) ‐ Open study; subjective measure |
| Incomplete outcome data (attrition bias) Adherence measure | Low risk | (PRIMARY) PILL COUNT ‐ Loss to follow‐up similar in the 2 groups |
| Incomplete outcome data (attrition bias) Patient outcome | Low risk | (PRIMARY) QUALITY OF LIFE (QLS) ‐ Loss to follow‐up similar in the 2 groups |