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Investigating the effect of a self-care package on people with COPD

Investigating the effect of implementing a combined self-care training package on sleep quality and fatigue in people with chronic obstructive pulmonary disease

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20260426069172N1
Enrollment
72
Registered
2026-05-04
Start date
2026-05-16
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic obstructive pulmonary disease. Chronic obstructive pulmonary disease, unspecified

Interventions

Intervention 1: Intervention group: Intervention group: First, they complete demographic questionnaires, Pittsburgh Sleep Quality, and Multidimensional Fatigue, then they receive a combined self-care

Sponsors

Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Confirmed diagnosis of moderate to severe chronic obstructive pulmonary disease by a pulmonologist (from the patient's file) - Patient is in stage II or III of the disease according to the GOLD classification (GOLD 2–3) according to the severity of airway obstruction Being literate Ability to use a smartphone Ability to participate in 30-minute training sessions and complete questionnaires Informed consent to participate in the study Not participating in other research at the same time Having at least one companion or primary caregiver who can attend in-person and virtual training sessions

Exclusion criteria

Exclusion criteria: Having a severe mental illness (such as major depression or schizophrenia) that prevents cooperation Presence of severe comorbidities (such as advanced heart failure or active cancer) Use of continuous breathing machines (such as CPAP), which directly affects sleep

Design outcomes

Primary

MeasureTime frame
Fatigue: A dependent variable, of a quantitative discrete type, measured with the Multidimensional Fatigue Questionnaire. Timepoint: Before and one month after the intervention. Method of measurement: Multidimensional Fatigue Questionnaire: This tool was developed to measure fatigue in patients with chronic diseases (such as cancer and respiratory diseases) and the general population, and is widely used due to its multidimensional nature. This questionnaire consists of 20 questions that assess 5 dimensions of fatigue in the past week: General fatigue (4 questions): A general feeling of exhaustion and lack of energy (e.g., “I feel tired”). Physical fatigue (4 questions): Fatigue related to physical activities (e.g., “I feel physically weak”). Decreased activity (4 questions): A decreased ability to perform daily tasks (e.g., “I do less work”). Decreased motivation (4 questions): A decreased interest or motivation for activities (e.g., “I have no interest in doing things”). Psychological fatigue (4 questions): Cognitive problems related to fatigue (e.g., “I have difficulty concentrating”). Each question is scored on a 5-point Likert scale (1=completely true, 5=completely false). To calculate the score for each dimension, the responses to the 4 related questions are summed (the scores for questions 1, 5, 9, 13, 15, and 17 are reversed to have a positive bias, i.e., a higher score indicates greater fatigue). The score for each dimension ranges from 4 to 20, and the total score for the questionnaire ranges from 20 to 100. A higher score indicates greater fatigue severity.

Secondary

MeasureTime frame
Sleep quality: It is a quantitative, discrete dependent variable, measured by the Pittsburgh Sleep Quality Questionnaire. Timepoint: Before and one month after the intervention. Method of measurement: Pittsburgh Sleep Quality Questionnaire: This instrument was developed to assess sleep quality in patients and the general population and is widely used in sleep studies due to its comprehensiveness and standardization. The Pittsburgh questionnaire consists of 19 self-report questions on a 4-point Likert scale and 5 additional questions (answered by the patient's roommate or spouse) that assess sleep quality over the past month. These 19 questions cover 7 components: Subjective sleep quality (1 question): The individual's perception of sleep quality (very good to very bad). Sleep latency (2 questions): The length of time it takes to fall asleep and the frequency of difficulty initiating sleep. Sleep duration (2 questions): The number of actual hours of sleep per night. Sleep efficiency (3 questions): The percentage of time in bed that the individual is actually asleep (relative to the total time in bed).Sleep disorders (9 questions): Frequency of sleep problems such as nighttime awakenings, breathing problems, or nightmares. Use of sleeping medications (1 question): Frequency of use of sleeping medications (prescription or over-the-counter). Impaired daily functioning (1 question): Problems with daily activities due to lack of sleep (such as drowsiness or concentration). Scoring method: Each component is scored on a scale of 0 to 3 based on the patient's responses to the relevant questions (0=no problem, 1=mild problem, 2=moderate problem, 3=severe problem).To calculate the score for each component, responses to related questions are combined (e.g., averaged or summed). The total score for this questionnaire is calculated by summing the scores for the 7 components (0 to 21). A score greater than 5 indicates poor sleep quality, and higher scores indicate greater severit

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad Amin Doostvandi

Iran University of Medical Sciences

gholamnejad.ha@iums.ac.ir+98 21 8871 4700

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jun 11, 2026