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P. Absetz trained health coaches (paid by Pfizer Oy). A. Auvinen’s and K. Tokola’s institution received grants from Joint Authority for Päijät-Häme Social and Health Care, Sitra, TEKES, and Pfizer Oy. J. Kytö was Medical Advisor for Pfizer Oy. Tom Wiklund was Medical Director of Pfizer Oy and had stock options of Pfizer Inc. Timo Ovaska was employee of Pfizer Oy. M. Talja’s institution received support for travel to meetings and fees for participation in review activities, and outside the submitted work for board membership, consultancy, employment, expert testimony and grants.
MT, AA, RKe, KP, RKu and TO participated in the design of the study (including conception, aims and procedures). EO, PA and TO took part in implementation of intervention. TW, KP, KH, MT, MN, RKe, RKu, PA and AA had oversight of the intervention throughout the study and the analysis, and planned the analysis. KT carried out data management and statistical analysis. All authors contributed to presentation and interpretation of findings. KP, AA and JK wrote the first draft. AA, KH, KP, JK, MN, MT, RKu, TW and PA took part in revision of the text for important intellectual content. All authors have approved the manuscript.
The aim was to evaluate the effect of a 12-month individualized health coaching intervention by telephony on clinical outcomes.
An open-label cluster-randomized parallel groups trial. Pre- and post-intervention anthropometric and blood pressure measurements by trained nurses, laboratory measures from electronic medical records (EMR). A total of 2594 patients filling inclusion criteria (age 45 years or older, with type 2 diabetes, coronary artery disease or congestive heart failure, and unmet treatment goals) were identified from EMRs, and 1535 patients (59%) gave consent and were randomized into intervention or control arm. Final analysis included 1221 (80%) participants with data on primary end-points both at entry and at end. Primary outcomes were systolic and diastolic blood pressure, serum total and LDL cholesterol concentration, waist circumference for all patients, glycated hemoglobin (HbA1c) for diabetics and NYHA class in patients with congestive heart failure. The target effect was defined as a 10-percentage point increase in the proportion of patients reaching the treatment goal in the intervention arm.
The proportion of patients with diastolic blood pressure initially above the target level decreasing to 85 mmHg or lower was 48% in the intervention arm and 37% in the control arm (difference 10.8%, 95% confidence interval 1.5–19.7%). No significant differences emerged between the arms in the other primary end-points. However, the target levels of systolic blood pressure and waist circumference were reached non-significantly more frequently in the intervention arm.
Individualized health coaching by telephony, as implemented in the trial was unable to achieve majority of the disease management clinical measures. To provide substantial benefits, interventions may need to be more intensive, target specific sub-groups, and/or to be fully integrated into local health care.
ClinicalTrials.gov Identifier: NCT00552903