Study design: This non blind randomized clinical trial study aimed to compare the effect of telephone and SMS follow-up of an empowerment program on QOL and fatigue in patients with COPD.
Participants: This study was conducted on the control group after obtaining the code of ethics (IR.SKUMS.REC.1398.104) and IRCT20170122032101N4 (6/4/2020) . The research population included patients with COPD admitted to Kashani and Hajar hospitals and physicians' offices in 2019. A sample size of 35 subjects in each group was calculated using the following formula:
Inclusion criteria were diagnosis of COPD grades 2 and 3 according to GOLD criteria (19), willingness to participate, ability to speak and communicate, the absence of hearing problems, literacy, having mobile and landline numbers, patient's ability to use SMS, age over 40 years (20), no participation in other empowerment programs during the last 6 months, and no history of the mental disorder according to the medical record and the physician's comment. The exclusion criteria included reluctance to continue participation, patient unavailability for 2 weeks or more, diseases making the patient unstable, and absence of more than 2 sessions in empowerment sessions (21).
Data collection: The research tools included a demographic information form (age, gender, smoking status, duration of disease, BMI, and literacy status), the St. George's Respiratory Questionnaire (SGRQ) for COPD patients' QOL, and the Standard Piper Fatigue Scale (PFS). For QOL, the SGRQ has three dimensions of symptoms, activity, and effectiveness, with a total of 17 questions. The symptom subscale has eight questions that measure cough, dyspnea, sputum, wheezing, and the number of recurrent attacks. The activity subscale contains two questions that examine the dyspnea-inducing physical activities or the effects of dyspnea on daily activities. The impact dimension includes seven questions and measures the disease's effect on one's social and emotional functioning. Each subscale of the questionnaire and its total score are a number between 0 and 100, indicating the best and the worst states of QOL. The Iranian version of this questionnaire was validated (α = 0.93) by Tafti et al. (2007) (2), and its reliability was calculated in the present study (0.82). The PFS, covering behavioral, emotional, perceptual, and cognitive dimensions, consists of 26 sentences. Of these sentences, 22 ones are scored in the range of 0-10 according to the severity of the signs. Scores of 0 and 10 indicate the lowest and the highest severities of the intended sign, respectively. Finally, the fatigue severity is obtained by summing the numbers selected by the patient and dividing the product by 22 as follows: 0 (non-fatigued), 1-3 (mild), 4-6 (moderate), and 4-7 (severe). Its validity was confirmed in a study by Khairi et al. (22), and its reliability was determined by Cronbach's alpha (0.91) in this study.
Intervention: Sampling was continued until achieving a total of 105 people. The empowerment program was started by obtaining informed consent from patients and coordination with the management, security, and audio-visual management of Hajar Hospital. The researcher held the program using lectures, questions/answers, and video projectors at Hajar Hospital twice a week, each lasting 90 min. The empowerment program used here was designed in line with the methods presented by Disler et al. (2016) (23) to empower patients with COPD.
At the start of the first session, the questionnaires were completed and returned to the researcher. During the empowerment sessions, an educational brochure was provided to all patients. The questionnaires were completed for the second time at the end of the sixth session. Afterward, the patients were assigned to three control, experimental one (telephone follow-up), and experimental two (SMS follow-up) groups using a random number table by the researcher. Numbers 1-105 prepared in the sixth session of each group were divided among the participants so that each subject was given a unique number. At the end of the empowerment program for all patients, each subject was included in one of the three groups according to the table of random numbers by the researcher. Blinding was not possible as each patient knew the type of follow-up intervention.
For 3 months (12), the researcher performed follow-ups were using landline and SMS service, and the control group received routine care. This stage of the study coincided with the COVID-19 epidemic. In the first month, the patients were followed up by telephone as 2 calls and then one call per week. For SMS follow-ups, pre-designed SMS as two SMS per week were sent in the first month and then one SMS per week.
Data analysis: At the end of the follow-up period, data were collected by demographic questionnaires, SGRQ for QOL, and PFS by someone other than the researcher and analyzed by SPSS 22 software using inferential and descriptive statistics (ANOVA and Correlation test) at a significance level of < 0.05 in all tests.