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临床试验/NCT07747571
NCT07747571尚未招募不适用

Factors Associated With Acceptance or Refusal of Participation in a Home-Based Pulmonary Telerehabilitation Program Among Adults With Chronic Obstructive Pulmonary Disease: A Retrospective Study

ADIR Association1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2026年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
50
试验地点
1
主要终点
Participation Decision Regarding Home-Based Pulmonary Telerehabilitation

研究概览

简要总结

Pulmonary rehabilitation improves symptoms, exercise capacity, and quality of life in people with chronic obstructive pulmonary disease (COPD), but access and participation may be limited by travel, organizational, logistical, and personal barriers. Home-based pulmonary telerehabilitation may reduce some of these barriers, although not all eligible individuals accept this mode of care. Identifying the characteristics associated with acceptance or refusal of this model is therefore essential to better define the population most likely to benefit from this approach, tailor the program's delivery and content, and identify potential remaining barriers in order to improve access to care.

This retrospective study will use existing data from adults with COPD who were screened at ADIR Association between May 2024 and April 2025 for an 8-week home-based pulmonary telerehabilitation feasibility study. Of 50 potentially eligible individuals, 21 accepted participation and 29 declined. Demographic, clinical, functional, psychological, and geographic characteristics will be compared between individuals who accepted and those who declined participation. Documented reasons for refusal will be described, and factors associated with refusal will be explored using logistic regression.

详细描述

ACCEPT-TELEREHAB is a single-center retrospective observational cohort study based on data collected during screening for the TELEREHAPP feasibility study (ClinicalTrials.gov identifier NCT05314686). The source cohort comprises all individuals with COPD who were screened and considered potentially eligible for an 8-week home-based pulmonary telerehabilitation program at ADIR Association between May 2024 and April 2025. Participants will be classified according to the decision recorded at screening: acceptance or refusal of the proposed telerehabilitation program.

Data will be extracted from the original screening file, medical records, and information available from the pulmonary rehabilitation referral and assessment. Variables of interest include age, sex, body mass index, COPD severity, comorbidities, available pulmonary function and exercise-test data, long-term oxygen therapy, dyspnea, quality of life, psychological status, functional exercise capacity, previous pulmonary rehabilitation, and the setting of any previous pulmonary rehabilitation program. When a reason for declining participation was documented, it will be coded retrospectively into descriptive categories; more than one category may be assigned to a single participant.

Home-to-center distance and estimated travel time will be derived using a standardized mapping procedure. The residential address available at screening will be used to calculate the fastest car journey to ADIR Association for a standardized arrival time of 9:00 AM on a working Tuesday outside public holidays and school vacations.

Continuous variables will be summarized using means and standard deviations or medians and interquartile ranges, as appropriate. The acceptance and refusal groups will be compared using independent-samples t tests or Wilcoxon-Mann-Whitney tests for continuous variables and chi-square or Fisher exact tests for categorical variables. Differences will be reported with 95% confidence intervals. Refusal to participate will be the dependent variable in univariable and multivariable logistic regression models. Results will be reported as odds ratios with 95% confidence intervals.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults with COPD who were screened at ADIR Association between May 2024 and April 2025 for an 8-week home-based pulmonary telerehabilitation feasibility study. Please refer to ClinicalTrials.gov identifier NCT05314686.

排除标准

  • Not applicable

研究组 & 干预措施

Group 1: Accepted Home-Based Pulmonary Telerehabilitation

Individuals who accepted participation in the original 8-week home-based pulmonary telerehabilitation feasibility study and were enrolled in that study. Expected source count: 21.

干预措施: No intervention (Other)

Group 2: Declined Home-Based Pulmonary Telerehabilitation

Individuals who were screened and considered potentially eligible for the original feasibility study but declined participation in the proposed home-based pulmonary telerehabilitation program. Expected source count: 29.

干预措施: No intervention (Other)

结局指标

主要结局

Participation Decision Regarding Home-Based Pulmonary Telerehabilitation

时间窗: At screening, before initiation of the proposed 8-week telerehabilitation program

The participation decision recorded at screening will be classified as acceptance or refusal of the proposed 8-week home-based pulmonary telerehabilitation program. The number and percentage of participants in each category will be reported.

次要结局

  • Documented Reasons for Refusal of Home-Based Pulmonary Telerehabilitation(At screening, when the participation decision was documented)
  • Distance From the Participant Residence to the Pulmonary Rehabilitation Center(At the time of screening)
  • Estimated Travel Time From the Participant Residence to the Pulmonary Rehabilitation Center(At the time of screening)
  • Age at screening(At the time of screening)
  • Sex distribution(At the time of screening)
  • Body mass index at screening(At the time of screening)
  • Chronic Obstructive Pulmonary Disease Severity(At the time of screening)
  • Long-term oxygen status(At the time of screening)
  • Modified Medical Research Council Dyspnea Scale Score(At the time of screening)
  • Visual Simplified Respiratory Questionnaire Score(At the time of screening)
  • Saint George's Respiratory Questionnaire(At the time of screening)
  • Hospital Anxiety and Depression Scale Anxiety Subscale Score(At the time of screening)
  • Hospital Anxiety and Depression Scale Depression Subscale Score(At the time of screeining)
  • Six-minute walk distance(At the time of screening)
  • Six-Minute Stepper Test Performance(At the time of screening)
  • One-Minute Sit-to-Stand Test Performance(At the time of screening)
  • Peak Oxygen Uptake During Cardiopulmonary Exercise Testing(At the time of screening)
  • Setting of Previous Pulmonary Rehabilitation(At the time of screening)
  • Pulmonary Function at Screening - Forced Expiratory Volume in 1 Second(At the time of screening)
  • Pulmonary Function at Screening - Forced Vital Capacity(At the time of screening)
  • Pulmonary Function at Screening - FEV1/FVC Ratio(At the time of screening)
  • Pulmonary Function at Screening - Residual Volume(At the time of screening)
  • Pulmonary Function at Screening - Total Lung Capacity(At the time of screening)
  • Pulmonary Function at Screening - Vital Capacity(At the time of screening)
  • Previous Participation in Pulmonary Rehabilitation(At the time of screening)
  • Distance From the Participant's Residence to the Pulmonary Rehabilitation Center(At the time of screening)
  • Age At Screening(At the time of screening)
  • Sex Distribution(At the time of screening)
  • Body Mass Index At Screening(At the time of screening)
  • Long-term oxygen Status(At the time of screening)
  • Hospital Anxiety and Depression Scale Depression Subscale Score(At the time of screening)
  • Six-Minute Walk Distance(At the time of screening)
  • Pulmonary Function at Screening - Slow Vital Capacity(At the time of screening)

研究者

发起方
ADIR Association
申办方类型
Other
责任方
Sponsor

研究点 (1)

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