Abstract
BackgroundPatients with heart failure (HF) reduced ejection fraction (HFrEF) have symptoms that are more severe and experience a higher rate of hospitalization compared with HF preserved ejection fraction (HFpEF) patients. However, symptom recognition cannot be made by patients based on current approaches. This problem is a barrier to effective self-care that needs to be improved by new self-monitoring instruments and strategies.ObjectiveThis study describes a protocol for the self-monitoring daily diaries of weight and shortness of breath (SOB) based on the traffic light system (TLS). The primary objective is to compare the self-care between the intervention and control group. Comparison of HF knowledge, HF quality of life (HFQOL), and all-cause hospitalization between the 2 groups are the secondary objectives.MethodsA single-blind randomized controlled trial is being conducted at the HF clinic at Tehran Heart Center (Tehran, Iran). Sixty-eight adult patients of both genders will be enrolled during admission to HF clinic. Eligible subjects will be assigned to either the intervention or control group by a block balanced randomization method. Baseline surveys will be conducted before random allocation. Participants in the intervention group will receive an integrated package consisting of (1) HF self-care education by an Australian Heart Foundation booklet on HF, (2) regular home self-monitoring of weight and SOB, and (3) scheduled call follow-ups for 3 months. Patients in the control group will receive no intervention and they only complete monthly surveys.ResultsThis study is ongoing and is expected to be completed by the end of 2018.ConclusionsThis is the first trial with new self-monitoring instruments in Iran as a low and middle-income country. If the findings show a positive effect, the package will be applied in different regions with the same health care status.Trial RegistrationIranian Registry of Clinical Trials IRCT2017021032476N1; https://en.irct.ir/trial/25296?revision=25296 (Archived by WebCite at http://www.webcitation.org/73DLICQL8)International Registered Report Identifier (IRRID)PRR1-10.2196/9209
Highlights
Heart failure (HF) is a complex clinical syndrome that results from any structural and functional impairment of ventricular filling or ejection of blood
This study is ongoing and is expected to be completed by the end of 2018. This is the first trial with new self-monitoring instruments in Iran as a low and middle-income country
If the findings show a positive effect, the package will be applied in different regions with the same health care status
Summary
This study describes a protocol for the self-monitoring daily diaries of weight and shortness of breath (SOB) based on the traffic light system (TLS). The primary objective is to compare the self-care between the intervention and control group. Comparison of HF knowledge, HF quality of life (HFQOL), and all-cause hospitalization between the 2 groups are the secondary objectives
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