The Effect of a Holistic Care Program on the Reduction of Iron Over Load in Patients with Beta-Thalassemia Major: A Randomized Clinical Trial

Increased iron load is the main problem in beta-thalassemia major; chelation therapy is used for its counteraction. Non-compliance with iron chelation therapy leads to certain complications and the economic burden caused by them further highlights the importance of therapies for reducing iron over load. Administering lower doses of the chelating agent reduces both the complications faced by the patients and the economic burden on the health system.
Objectives and This randomized clinical trial was conducted to investigate the effect of a holistic care program (HCP) on the reduction of iron over load in patients with beta-thalassemia major had been referred to the largest center for thalassemic patients in Mashhad (Iran). The study lasted from September 2012 to February 2015. Based on the estimated sample size, 90 of the eligible subjects were randomly selected. The subjects gave their informed consent and were then divided into an intervention (n = 45) and control group (n = 45) through stratified randomization while taking into account the type of chelator agent as the confounder. The HCP was conducted as a randomized trial in 3 parts: 1- individual counseling (4 45 - 60-min sessions for each patient), 2- group training (4 60 - 90-min sessions for each patient), and 3- rehabilitation (8 weeks). Of the 500 patients with beta-thalassemia major, 90 samples were randomly selected. After they gave their informed consent, the samples were randomly assigned to 2 groups, i.e. an HCP group and a control group. Before beginning the intervention and 3 months later, the patients’ levels of serum ferritin and iron, total iron binding capacity or TIBC (to check the iron load), and hemoglobin or Hgb (to prevent hemolysis) were examined and the 6-minute walk test (6MWT) was also performed for assessing their functional ability and to ensure they were able to comply with the rehabilitation program. The patients in the control group received routine care only. The pre- and post-intervention evaluations in the control group were similar to those in the intervention group.
Changes in serum iron and ferritin as well as the 6MWT distance differed significantly between the test and control groups (P 0.05). The mean changes in serum iron and ferritin, 6MWT, TIBC, and Hb equaled -71.02 ± 97.28, -1172.75 ± 2032.14, 65.97 ± 81.1, 29.71 ± 80.95, and 0.06 ± 1.75 in the intervention group and -5.46 ± 96.73, -8.08 ± 998.56, -33.97 ± 54.28, 21.37 ± 90.45, and 0.33 ± 1.5 in the control group.
It seems that any change in the mental and psychological conditions of chronic patients, especially those with thalassemia, improves their self-care behaviors and thereby, their treatment compliance. Based on the results, the HCP was effective in reducing ferritin levels in patients with thalassemia major in this study. Therefore, this is program is recommended to be used in the care of thalassemia patients.