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. 2018 Nov 14;7(11):e184.
doi: 10.2196/resprot.9209.

Self-Monitoring by Traffic Light Color Coding Versus Usual Care on Outcomes of Patients With Heart Failure Reduced Ejection Fraction: Protocol for a Randomized Controlled Trial

Mahin Nomali  1 , Ramin Mohammadrezaei  2 , Abbas Ali Keshtkar  3 , Gholamreza Roshandel  4 , Shahrzad Ghiyasvandian  5 , Kian Alipasandi  6 , Masoumeh Zakerimoghadam  7
Affiliations

Self-Monitoring by Traffic Light Color Coding Versus Usual Care on Outcomes of Patients With Heart Failure Reduced Ejection Fraction: Protocol for a Randomized Controlled Trial

Mahin Nomali et al. JMIR Res Protoc. .

Abstract

Background: Patients 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.

Objective: 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.

Methods: A 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.

Results: This study is ongoing and is expected to be completed by the end of 2018.

Conclusions: 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.

Trial registration: Iranian 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.

Keywords: clinical trial; heart failure; outcome; self-monitoring.

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Conflict of interest statement

Conflicts of Interest: None declared.

Figures

Figure 1
Figure 1
Colored weight daily diary. EMS: emergency medical services.
Figure 2
Figure 2
Colored shortness of breath daily diary. EMS: emergency medical services.
Figure 3
Figure 3
Flowchart of actions recommended by research nurse based on color zones of each subject's self-monitoring daily diary during call follow-ups. ED: emergency department; EMS: emergency medical services; SOB: shortness of breath.
Figure 4
Figure 4
Flowchart of the research nurse recommendations for each symptom reported by subjects in the intervention group during the call follow-ups.
Figure 5
Figure 5
Schematic representation of the study design. HF: heart failure.
See this image and copyright information in PMC

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