A Scoping Study to Evaluate the Potential of an Electronic Medical Device to Treat Anxiety in People Who Experience Breathlessness.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 3
- 主要终点
- Acceptability and tolerability
研究概览
简要总结
The goal of this mixed methods study is to learn about cranial electrotherapy stimulation (CES) using Alpha-Stim AID in anxiety related to breathlessness in advanced lung diseases. The main question[s] it aims to answer are:
- Is CES using Alpha-Stim AID acceptable and tolerable as a potential treatment in the management of anxiety in patients who experience breathlessness due to advanced chronic respiratory disease?
- What are the key factors that will inform the design of a study to examine its potential clinical effectiveness? Participants will choose whether they want to trial the CES for eight weeks or be in a parallel control group. They will complete daily diaries, questionnaires about anxiety, breathlessness, sleep, quality of life and depression, and an end of study qualitative interview.
Researchers will compare those using the CES and those receiving standard care to see if there are any indications of difference in anxiety and other symptoms experienced.
详细描述
This is a two-site, mixed-methods, non-commercial interventional scoping study with a parallel non-randomised control group at LOROS Hospice (Leicester) and Northamptonshire Healthcare NHS Foundation Trust (NHFT) for patients with anxiety related to breathlessness secondary to advanced chronic respiratory disease.
Clinicians at both sites regularly complete the IPOS questionnaire as part of standard clinical practice. Patients who attend the HWB service will be screened for eligibility and approached by the research team for informed consent taking. Participants may choose to be in the intervention group or control group if places are available and the reasons for this choice will be noted in the CRF. This is in order to inform our feasibility objective for a future study.
Participants in the intervention group will receive an Alpha-Stim AID device with instruction on its use. The intervention is a single 60-minute session per day in their own home at a current of 100μA. This dose and/or duration of treatment may be modified at day 3 and/or day 5 in response to side effects as shown in the flowchart below (with a further review at day 7 if changes are made at day 5). Changes in the regime will be made after consultant with a medic (either CI or site PI).
The treatment period is 8 weeks, with a further 4 weeks of follow-up, totalling 12 weeks. The control group will be followed up for 12 weeks.
Demographic details and outcome measures will be recorded at baseline. A number of quantitative outcome measures will be collected in a daily log, at baseline, and weeks 2, 4, 8 and 12. Qualitative data via a semi-structured interview is sought from participants at the completion of the treatment and intervention period, or on withdrawal from either group unless due to significant clinical deterioration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- 否
入选标准
- •Aged 18 years or above. There is no upper age limit.
- •Diagnosis of advanced chronic lung disease, including Chronic Obstructive Pulmonary Disease (COPD), Interstitial Lung Disease (ILD), or Pulmonary Fibrosis of any aetiology.
- •Currently receiving care at LOROS or Cynthia Spencer Hospice.
- •A score of 3 or 4 on IPOS Q2 for shortness of breath.
- •A score of 2 or more on IPOS Q3 anxious or worried.
- •Capable of giving oral and written informed consent to the study.
- •Agrees to return the Alpha-Stim AID device at the end of the study and not to purchase the device privately during the study.
- •Estimated prognosis of >3 months at the time of recruitment.
排除标准
- •Implantation with a pacemaker, cochlear implant, or an implantable cardioverter device (ICD).
- •Neurological conditions, e.g. brain neoplasm, cerebrovascular events, epilepsy, neurodegenerative disorders, or prior brain surgery.
- •Currently pregnant or planning a pregnancy.
- •Involved with any other clinical trial at the time of consent.
结局指标
主要结局
Acceptability and tolerability
时间窗: 2,4,8 and 12 weeks
qualitative text entries in daily log and analysis of end of study interviews will be triangulated with adverse effects (number of participants experiencing AE thought to be causally related to the CES, severity, and duration) and in comparison to those in control arm. We do not anticipate SAE to be a feature of the study.
次要结局
- Anxiety(baseline, 2, 4, 8 and 12 weeks)