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Effects of person-centered care using a digital platform and structured telephone support for people with chronic obstructive pulmonary disease and chronic heart failure: randomized controlled trial
Ali L, Wallstrom S, Fors A, Barenfeld E, Fredholm E, Fu M, Goudarzi M, Gyllensten H, Kjellberg IL, Lindstrom Kjellberg I, Swedberg K, Vanfleteren LEGW, Ekman I
Journal of Medical Internet Research 2021 Dec;23(12):e26794
clinical trial
6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; 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*

BACKGROUND: Chronic obstructive pulmonary disease (COPD) and chronic heart failure (CHF) are characterized by severe symptom burden and common acute worsening episodes that often require hospitalization and affect prognosis. Although many studies have shown that person-centered care (PCC) increases self-efficacy in patients with chronic conditions, studies on patients with COPD and CHF treated in primary care and the effects of PCC on the risk of hospitalization in these patients are scarce. OBJECTIVE: The aim of this study is to evaluate the effects of PCC through a combined digital platform and telephone support for people with COPD and CHF. METHODS: A multicenter randomized trial was conducted from 2018 to 2020. A total of 222 patients were recruited from 9 primary care centers. Patients diagnosed with COPD, CHF, or both and with internet access were eligible. Participants were randomized into either usual care (112/222, 50.5%) or PCC combined with usual care (110/222, 49.5%). The intervention's main component was a personal health plan cocreated by the participants and assigned health care professionals. The health care professionals called the participants in the intervention group and encouraged narration to establish a partnership using PCC communication skills. A digital platform was used as a communication tool. The primary end point, divided into 2 categories (improved and deteriorated or unchanged), was a composite score of change in general self-efficacy and hospitalization or death 6 months after randomization. Data from the intention-to-treat group at 3- and 6-month follow-ups were analyzed. In addition, a per-protocol analysis was conducted on the participants who used the intervention. RESULTS: No significant differences were found in composite scores between the groups at the 3- and 6-month follow-ups. However, the per-protocol analysis of the 3-month follow-up revealed a significant difference in composite scores between the study groups (p = 0.047), although it was not maintained until the end of the 6-month follow-up (p = 0.24). This effect was driven by a change in general self-efficacy from baseline. CONCLUSIONS: PCC using a combined digital platform and structured telephone support seems to be an option to increase the short-term self-efficacy of people with COPD and CHF. This study adds to the knowledge of conceptual innovations in primary care to support patients with COPD and CHF. TRIAL REGISTRATION: ClinicalTrials.gov NCT03183817; http://clinicaltrials.gov/ct2/show/NCT03183817.

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