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临床试验/NCT04946708
NCT04946708已完成不适用

Using Technology to Engage Patients With Interstitial Lung Disease (ILD) in a Home a Home Exercise Program.

University of Manitoba2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2021年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
14
试验地点
2
主要终点
Changes in health-related quality of life (HRQoL)

研究概览

简要总结

Design: this pilot-study uses a two-group random assignment pretest-posttest design. Once the groups are being selected an envelope will be mailed to the participant with the printed version of the exercise program and surveys, a portable SpiroBank Smart FN multi parameter spirometer (MIR), a finger pulse oximeter (LOOKEE), a diary, and a prepaid envelop for a subsequent post-intervention return of the equipment and surveys and the diary.

Intervention: A) Exercise program: evidence-based and user friendly educational materials with recommendations on breathing and physical exercises will be developed. B) Patients intake: in a zoom meeting, a registered therapist (Pl) in charge of implementing the intervention will request informed consent to participate in the study, explain specifics of the intervention to each participant, and will conduct an initial assessment. C) Intervention (8 weeks): using the participants' initial assessment and personal characteristics, the therapist will provide personalized recommendations (e.g. maximum heart rate, minimum Sp02), explain the educational materials, and instruct patients on safety precautions (how to pace themselves, when to seek professional or emergency care). All participants (and immediate caregiver I necessary) will receive training: 1) basic device management (join a zoom meeting, watch a YouTube video), 2) use of the portable spirometer and its associated app, 3) use of finger pulse oximeter and 4) recording of the values in a dairy. Group one: will be asked to follow the exercise program with a small group of peers (2 groups/6 participants each) in a zoom meeting 3 times a week/45 min each {including 5 min before and 10 min after the meeting for free talk-chat between the participants e.g. questions, perceptions, etc.). The therapist will lead the first three meetings, gradually encourage participants to take turns leading the exercises with the goal of identifying /empowering potential patient leaders. Beginning with the fourth meeting, participants will be encouraged to connect to the meeting and follow their exercise program on their own, taking into account their individualized recommendations. The RA will organize and attend the zoom meetings to resolve general questions (e.g. equipment, platforms, etc.) and will act as a direct point of contact between the therapist and the participants. Group two: will be asked to follow the exercise program 3 times a week/30 min each while watching a pre-recorded YouTube video. D) Self-monitoring: patients will be asked to wear the finger pulse oximeter at all times while exercising, so that they can control their pace while avoiding exceeding target values (HR, Sp02). They will be asked to record in their HR and Sp02 values before and after participation in every session of the exercise program in a diary. E) Support: participants will be able to contact the therapist at any time during the study if they have questions or concerns. Otherwise, they will receive a follow-up phone call once a week from the RA.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

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

  • Clinical diagnosis of interstitial lung disease
  • Access to a smart phone or tablet and home internet

排除标准

  • Acute exacerbation of their ILDs condition
  • History of neurological disease or mental illness
  • Inability to ambulate independently without supervision
  • Inability to complete basic tasks on a smart phone or tablet

结局指标

主要结局

Changes in health-related quality of life (HRQoL)

时间窗: 8 weeks

Assessed with the King's Brief Interstitial Lung Disease (KBILD), which is an ILD-specific measure of HRQoL. Total score ranges are 0-100 (100 represents best HRQoL).

Change in dyspnea

时间窗: 8 weeks

Modified Borg Scale (0 "none" to 10 "maximum") will be used to assess dyspnea.

Change in post-exercise saturation

时间窗: 8 weeks

SpO2 will be measured using a digital fingertip pulse oximeter before-after the one- minute sit-to-stand test.

Change in fatigue

时间窗: 8 weeks

Fatigue severity scale (0 -7 "higher worse") will be used to measure the severity of fatigue.

Change in exercise capacity

时间窗: 8 weeks

Assessed with the one-minute sit-to-stand test (number of times the persons can complete the task in one minute).

Change in physical function

时间窗: 8 weeks

Assessed using the EQ-5D-5L scale (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) (0-100 higher better function).

Change in lung capacity

时间窗: 8 weeks

It will be assessed using a SpiroBank Smart F/V multi parameter spirometer (MIR) at pre-post intervention and once a week in between to monitor changes. This portable spirometer, which is MDSAP approved and complaint with ATS/ERS guidelines, connects automatically via Bluetooth to an iOS \& Android compatible App (MIR Spirobank). It provides real time feedback through messages and animation on smartphone, to improve personal compliance during the test. The app can generate test results PDF printout with information regarding 19 parameters of lung capacity.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Diana C Sanchez-Ramirez, PhD

Assistant professor

University of Manitoba

研究点 (2)

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