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The effects of a telehealth coping skills intervention on outcomes in chronic obstructive pulmonary disease: primary results from the INSPIRE-II study |
Blumenthal JA, Emery CF, Smith PJ, Keefe FJ, Welty-Wolf K, Mabe S, Martinu T, Johnson JJ, Babyak MA, O'Hayer VF, Diaz PT, Durheim M, Baucom D, Palmer SM |
Psychosomatic Medicine 2014 Oct;76(8):581-592 |
clinical trial |
7/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
OBJECTIVE: Chronic obstructive pulmonary disease (COPD) is associated with increased morbidity and mortality and reduced quality of life (QoL). Novel interventions are needed to improve outcomes in COPD patients. The present study assessed the effects of a telephone-based coping skills intervention on psychological and somatic QoL and on the combined medical end point of COPD-related hospitalizations and all-cause mortality. METHODS: We conducted a dual-site, randomized clinical trial with assessments at baseline and after 16 weeks of treatment. The study population comprised 326 outpatients with COPD aged 38 to 81 years, randomized to coping skills training (CST) or to COPD education (COPD-ED). Patients completed a battery of QoL instruments, pulmonary function tests, and functional measures and were followed up for up to 4.4 years to assess medical outcomes. RESULTS: The CST group exhibited greater improvements in psychological QoL compared with controls (p = 0.001), including less depression (Cohen d = 0.22 (95% confidence interval, or CI 0.08 to 0.36)) and anxiety (d = 0.17 (95% CI 0.02 to 0.33)), and better overall mental health (d = 0.17 (95% CI 0.03 to 0.32)), emotional role functioning (d = 0.29 (95% CI 0.10 to 0.48)), vitality (d = 0.27 (95% CI 0.11, 0.42)), and social functioning (d = 0.21 (95% CI 0.03 to 0.38)). A significant baseline psychological QoL by treatment group interaction revealed that CST with lower QoL at baseline achieved even greater improvements in psychological QoL compared with COPD-ED. CST participants also exhibited greater improvements in somatic QoL (p = 0.042), including greater improvements in pulmonary QoL (d = 0.13 (95% CI 0.01 to 0.24)), less fatigue (d = 0.34 (95% CI 0.18 to 0.50)), and less shortness of breath (d = 0.11 (95% CI -0.01 to 0.23)) and greater improvement in distance walked on the Six-Minute Walk test (d = 0.09 (95% CI 0.01 to 0.16)). However, there was no significant difference in risk of time to COPD-related hospitalization or all-cause mortality between CST (34 events) and COPD-ED (32 events; p = 0.430). CONCLUSIONS: A telehealth CST intervention produced clinically meaningful improvements in QoL and functional capacity, but no overall improvement in risk of COPD-related hospitalization and all-cause mortality. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT00736268.
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