Feasibility, Acceptability And Usability Of The InControl Web Platform - A Rando Mized Parallel-Group Pilot Study of Mixed-methods (InControl)
2026年8月18日 更新者：Anabela G Silva、Aveiro University
Feasibility, Acceptability And Usability Of The InControl Web Platform - A Mixed-methods Pilot Study
This is a randomized, parallel-group pilot study that employs mixed methods (qualitative and quantitative approaches). The purpose of this study is to assess the feasibility, usability, and acceptability of an intervention with a digital component on the InControl web platform. The intervention is based on education in pain science and exercise, with the goal of managing chronic musculoskeletal pain in older adults. The intervention will be delivered through a combination of digital and in-person components and it will be compared to the usual intervention.
It will also inform the design of a randomized controlled trial to evaluate the cost-effectiveness of InControl.
研究概览
研究类型
介入性
注册 (估计的)
34
阶段
- 不适用
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- be 60 years or older;
- have chronic musculoskeletal pain, defined as pain that persists for more than three months and is felt in the muscles, bones, joints, or tendons at least once a week;
- know how to use a computer and/or a tablet; iv) have a score of 3 or higher on the Numerical Pain Scale for average pain intensity over the past week;
- show no cognitive impairment, as determined by the Montreal Cognitive Assessment (MoCA) (validated and with normative data for the Portuguese population) and be available to participate in the study. The MoCA cutoff scores for the absence of cognitive impairment to be considered are adjusted for the participants' age and educational level [primary school (1-4 years), middle school (5-9 years), high school (10-12 years), and college (>12 years)], with 1.5 standard deviations: i) Ages 60-69: elementary school - 17 points, middle school - 21 points, high school and college - 22 points; ii) Ages 70-79: elementary school - 15 points, middle school - 18 points, high school - 20 points, and college - 22 points; iii) Over 80 years old: elementary school - 12 points, middle school - 22 points, high school - 17 points, and college - 19 points.
Exclusion Criteria:
- inability to read;
- pain associated with serious conditions (e.g., tumors, fractures);
- any acute, unstable, or decompensated medical conditions that prevent safe physical exercise. Examples include cardiovascular diseases (recent acute myocardial infarction, unstable angina, uncontrolled cardiac arrhythmias, severe symptomatic aortic stenosis, symptomatic or unstable heart failure, acute myocarditis or pericarditis, acute aortic dissection, active endocarditis, uncontrolled hypertension), respiratory conditions (acute pulmonary embolism, pulmonary infarction, chronic obstructive pulmonary disease, uncontrolled asthma, or recent respiratory exacerbations), metabolic conditions (uncontrolled diabetes mellitus), neurological conditions (stroke, traumatic brain injury, Parkinson's disease), or acute systemic infection.
- In addition, participants will be screened according to the American College of Sports Medicine's Preparticipation Health Screening algorithm
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他：日常护理
|
Usual care is defined as the treatment that the participant would normally receive such as medication, physical therapy, or any other form of treatment.
其他名称：
|
|
实验性的：InControl intervention
|
The InControl intervention lasts 8 weeks and combines educational content on pain science and exercise on a digital platform.
InControl is the result of a co-creation process between healthcare professionals and older adults with lived experience of chronic musculoskeletal pain.
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Rates
大体时间：From enrollment to the end of treatment at 8 weeks
|
inclusion, refusal, exclusion, dropout and retetion
|
From enrollment to the end of treatment at 8 weeks
|
|
System Usability Scale
大体时间：At the end of 8 weeks of intervention
|
Usability evatuated wiht the portuguese version of SUS The score ranges from 0 to 100.
Higher scores are interpreted as indicating better usability.
|
At the end of 8 weeks of intervention
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Estructured questionnaire to assess aceptability
大体时间：At the end of 8 weeks of intervention
|
Estructured questionnaire Ten items, with scores ranging from 1 - totally disagree to 5 - totally agree
|
At the end of 8 weeks of intervention
|
|
Semi-structured interview
大体时间：At the end of 8 weeks of intervention
|
Semi-structured interview to explore participants' perceptions about programme acceptability
|
At the end of 8 weeks of intervention
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Sex
大体时间：Baseline
|
Please indicate the appropriate option: male, female, prefer not to say, other (please specify)
|
Baseline
|
|
Age
大体时间：Baseline
|
number of years
|
Baseline
|
|
Marital status
大体时间：Baseline
|
Select your marital status: Single, Married, In a civil partnership, Divorced Widowed
|
Baseline
|
|
Level of education
大体时间：Baseline
|
Please select your level of education: Can read and write; 4th year of schooling; 6th year of schooling; 9th year of schooling; 12th year of schooling; Bachelor's degree; Other (please specify)
|
Baseline
|
|
Employment status
大体时间：Baseline
|
Please select: Full-time employee, Part-time employee, Domestic worker, Unemployed, Retired, Temporarily unfit for work
|
Baseline
|
|
Weight
大体时间：Baseline
|
weight in kilograms
|
Baseline
|
|
Height
大体时间：Baseline
|
height, in metres
|
Baseline
|
|
Falls
大体时间：Baseline
|
number of falls in the last year
|
Baseline
|
|
Number of medicines
大体时间：Baseline
|
number of regular medicines
|
Baseline
|
|
Comorbidities
大体时间：Baseline
|
Please select: No medical conditions, High blood pressure, Diabetes, Osteoarthritis (please specify the affected area), Cardiovascular conditions, Respiratory conditions, Neurological conditions, Cancer, Arthritis, Osteoporosis, Vision problems, Hearing problems, Other (please specify)
|
Baseline
|
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EQ-5D-5L
大体时间：At baseline and at the end of the 8-week intervention
|
The EQ-5D-5L score ranges from 1 to 5 for each domain
|
At baseline and at the end of the 8-week intervention
|
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EQ-VAS
大体时间：At baseline and at the end of the 8-week intervention
|
The score of EQ-VAS ranges from 0 to 100.
Higher scores are interpreted as indicating a better perception of health quality
|
At baseline and at the end of the 8-week intervention
|
|
Montreal Cognitive Assessment
大体时间：At baseline and at the end of the 8-week intervention
|
MoCA scores range from 0 to 30.
Higher scores indicate better cognitive performance
|
At baseline and at the end of the 8-week intervention
|
|
Brief Pain Inventory
大体时间：At baseline and at the end of the 8-week intervention
|
On the pain severity subscale, scores range from 0 to 40 points.
On the pain-related interference subscale, scores range from 0 to 70 points.
Higher scores indicate greater severity or pain-related interference, respectively
|
At baseline and at the end of the 8-week intervention
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Location and number of painful sites
大体时间：At baseline and at the end of the 8-week intervention
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Bodychart
|
At baseline and at the end of the 8-week intervention
|
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PainDETECT Questionnaire
大体时间：At baseline and at the end of 8-week intervention
|
The score ranges from -1 to 38 points
|
At baseline and at the end of 8-week intervention
|
|
Hand grip strength
大体时间：At baseline and at the end of 8-week intervention
|
Kg
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At baseline and at the end of 8-week intervention
|
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Gait speed test
大体时间：At baseline and at the end of 8-week intervention
|
metres per second
|
At baseline and at the end of 8-week intervention
|
|
5-sit-to-stand test
大体时间：At baseline and at the end of 8-week intervention
|
time in seconds
|
At baseline and at the end of 8-week intervention
|
|
Rapid Assessment of Physical Activity
大体时间：At baseline and at the end of 8-week intervention
|
Depending on physical activity, there are five levels of physical activity: sedentary - item 1, ii) slightly active - item 2, iii) regularly slightly active (light activity) - item 3, iv) regularly slightly active - items 4 and 5, and v) active - items 6 and 7
|
At baseline and at the end of 8-week intervention
|
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Pain Catastrophizing Scale
大体时间：At baseline and at the end of 8-week intervention
|
The minimum score is 0 and the maximum is 52.
Higher scores are associated with higher levels of catastrophic thinking
|
At baseline and at the end of 8-week intervention
|
|
Tampa Scale of Kinesiophobia
大体时间：At baseline and at the end of 8-week intervention
|
Scores range from 13 to 52 points.
Higher scores are associated with greater fear of movement
|
At baseline and at the end of 8-week intervention
|
|
Geriatric Depression Scale
大体时间：At baseline and at the end of 8-week intervention
|
Scores range from 0 to 15.
Higher scores indicate more depressive symptoms
|
At baseline and at the end of 8-week intervention
|
|
Strength, Assistance with walking, Rise from a chair, Climb stairs and Falls
大体时间：At baseline and at the end of 8-week intervention
|
SARC-F.
Scores range from 0 to 10.
Total scores of 4 or above are suggestive of sarcopenia
|
At baseline and at the end of 8-week intervention
|
|
Patient Global Impression of Change
大体时间：At the end of 8-week intervention
|
Scores range from 1 to 7. Higher scores indicate a greater overall perception of improvement
|
At the end of 8-week intervention
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Anabela G. Silva, PhD、University of Aveiro
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年9月1日
初级完成 (估计的)
2026年12月1日
研究完成 (估计的)
2026年12月1日
研究注册日期
首次提交
2026年7月28日
首先提交符合 QC 标准的
2026年8月18日
首次发布 (实际的)
2026年8月19日
研究记录更新
最后更新发布 (实际的)
2026年8月19日
上次提交的符合 QC 标准的更新
2026年8月18日
最后验证
2026年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.