BACKGROUND: Increases in life stress have been linked to poor prognosis, after myocardial infarction (MI). Previous research suggested that a programme of monthly screening for psychological distress, combined with supportive and educational home nursing interventions for distressed patients, may improve post-MI survival among men. Our study assessed this approach for both men and women. We aimed to find out whether the programme would reduce 1-year cardiac mortality for women and men. METHODS: We carried out a randomised, controlled trial of 1376 post-MI patients (903 men, 473 women) assigned to theintervention programme (n = 692) or usual care (n = 684) for 1 year. All patients completed a baseline interview that included assessment of depression and anxiety. Survivors were also interviewed at 1 year. FINDINGS: The programme had no overall survival impact. Preplanned analyses showed higher cardiac (9.4 vs 5.0%, p = 0.064) and all-cause mortality (10.3 vs 5.4%, p = 0.051) among women in the intervention group. There was no evidence of either benefit or harm among men (cardiac mortality 2.4 vs 2.5%, p = 0.94; all-cause mortality 3.1 vs 3.1%, p = 0.93). The programme's impact on depression and anxiety among survivors was small. INTERPRETATION: Our results do not warrant the routine implementation of programmes that involve psychological-distress screening and home nursing intervention for patients recovering from MI. The poorer overall outcome for women, and the possible harmful impact of the intervention on women, underline the need for further research and the inclusion of adequate numbers of women in future post-MI trials.
RCT Entities:
BACKGROUND: Increases in life stress have been linked to poor prognosis, after myocardial infarction (MI). Previous research suggested that a programme of monthly screening for psychological distress, combined with supportive and educational home nursing interventions for distressed patients, may improve post-MI survival among men. Our study assessed this approach for both men and women. We aimed to find out whether the programme would reduce 1-year cardiac mortality for women and men. METHODS: We carried out a randomised, controlled trial of 1376 post-MI patients (903 men, 473 women) assigned to the intervention programme (n = 692) or usual care (n = 684) for 1 year. All patients completed a baseline interview that included assessment of depression and anxiety. Survivors were also interviewed at 1 year. FINDINGS: The programme had no overall survival impact. Preplanned analyses showed higher cardiac (9.4 vs 5.0%, p = 0.064) and all-cause mortality (10.3 vs 5.4%, p = 0.051) among women in the intervention group. There was no evidence of either benefit or harm among men (cardiac mortality 2.4 vs 2.5%, p = 0.94; all-cause mortality 3.1 vs 3.1%, p = 0.93). The programme's impact on depression and anxiety among survivors was small. INTERPRETATION: Our results do not warrant the routine implementation of programmes that involve psychological-distress screening and home nursing intervention for patients recovering from MI. The poorer overall outcome for women, and the possible harmful impact of the intervention on women, underline the need for further research and the inclusion of adequate numbers of women in future post-MI trials.
Authors: C Noel Bairey Merz; James Dwyer; Cheryl K Nordstrom; Kenneth G Walton; John W Salerno; Robert H Schneider Journal: Behav Med Date: 2002 Impact factor: 3.104