Feasibility, Acceptability And Usability Of The InControl Web Platform - A Rando Mized Parallel-Group Pilot Study of Mixed-methods (InControl)
2026년 8월 18일 업데이트: 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.
연구 개요
연구 유형
중재적
등록 (추정된)
34
단계
- 해당 없음
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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다른: 평소 케어
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Usual care is defined as the treatment that the participant would normally receive such as medication, physical therapy, or any other form of treatment.
다른 이름들:
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실험적: InControl intervention
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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.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Rates
기간: From enrollment to the end of treatment at 8 weeks
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inclusion, refusal, exclusion, dropout and retetion
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From enrollment to the end of treatment at 8 weeks
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System Usability Scale
기간: At the end of 8 weeks of intervention
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Usability evatuated wiht the portuguese version of SUS The score ranges from 0 to 100.
Higher scores are interpreted as indicating better usability.
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At the end of 8 weeks of intervention
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Estructured questionnaire to assess aceptability
기간: At the end of 8 weeks of intervention
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Estructured questionnaire Ten items, with scores ranging from 1 - totally disagree to 5 - totally agree
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At the end of 8 weeks of intervention
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Semi-structured interview
기간: At the end of 8 weeks of intervention
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Semi-structured interview to explore participants' perceptions about programme acceptability
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At the end of 8 weeks of intervention
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Sex
기간: Baseline
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Please indicate the appropriate option: male, female, prefer not to say, other (please specify)
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Baseline
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Age
기간: Baseline
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number of years
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Baseline
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Marital status
기간: Baseline
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Select your marital status: Single, Married, In a civil partnership, Divorced Widowed
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Baseline
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Level of education
기간: Baseline
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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)
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Baseline
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Employment status
기간: Baseline
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Please select: Full-time employee, Part-time employee, Domestic worker, Unemployed, Retired, Temporarily unfit for work
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Baseline
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Weight
기간: Baseline
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weight in kilograms
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Baseline
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Height
기간: Baseline
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height, in metres
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Baseline
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Falls
기간: Baseline
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number of falls in the last year
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Baseline
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Number of medicines
기간: Baseline
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number of regular medicines
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Baseline
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Comorbidities
기간: Baseline
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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)
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Baseline
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EQ-5D-5L
기간: At baseline and at the end of the 8-week intervention
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The EQ-5D-5L score ranges from 1 to 5 for each domain
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At baseline and at the end of the 8-week intervention
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EQ-VAS
기간: At baseline and at the end of the 8-week intervention
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The score of EQ-VAS ranges from 0 to 100.
Higher scores are interpreted as indicating a better perception of health quality
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At baseline and at the end of the 8-week intervention
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Montreal Cognitive Assessment
기간: At baseline and at the end of the 8-week intervention
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MoCA scores range from 0 to 30.
Higher scores indicate better cognitive performance
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At baseline and at the end of the 8-week intervention
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Brief Pain Inventory
기간: At baseline and at the end of the 8-week intervention
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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
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At baseline and at the end of the 8-week intervention
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Location and number of painful sites
기간: At baseline and at the end of the 8-week intervention
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Bodychart
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At baseline and at the end of the 8-week intervention
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PainDETECT Questionnaire
기간: At baseline and at the end of 8-week intervention
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The score ranges from -1 to 38 points
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At baseline and at the end of 8-week intervention
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Hand grip strength
기간: At baseline and at the end of 8-week intervention
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Kg
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At baseline and at the end of 8-week intervention
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Gait speed test
기간: At baseline and at the end of 8-week intervention
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metres per second
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At baseline and at the end of 8-week intervention
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5-sit-to-stand test
기간: At baseline and at the end of 8-week intervention
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time in seconds
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At baseline and at the end of 8-week intervention
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Rapid Assessment of Physical Activity
기간: At baseline and at the end of 8-week intervention
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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
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At baseline and at the end of 8-week intervention
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Pain Catastrophizing Scale
기간: At baseline and at the end of 8-week intervention
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The minimum score is 0 and the maximum is 52.
Higher scores are associated with higher levels of catastrophic thinking
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At baseline and at the end of 8-week intervention
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Tampa Scale of Kinesiophobia
기간: At baseline and at the end of 8-week intervention
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Scores range from 13 to 52 points.
Higher scores are associated with greater fear of movement
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At baseline and at the end of 8-week intervention
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Geriatric Depression Scale
기간: At baseline and at the end of 8-week intervention
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Scores range from 0 to 15.
Higher scores indicate more depressive symptoms
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At baseline and at the end of 8-week intervention
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Strength, Assistance with walking, Rise from a chair, Climb stairs and Falls
기간: At baseline and at the end of 8-week intervention
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SARC-F.
Scores range from 0 to 10.
Total scores of 4 or above are suggestive of sarcopenia
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At baseline and at the end of 8-week intervention
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Patient Global Impression of Change
기간: At the end of 8-week intervention
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Scores range from 1 to 7. Higher scores indicate a greater overall perception of improvement
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At the end of 8-week intervention
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Anabela G. Silva, PhD, University of Aveiro
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 9월 1일
기본 완료 (추정된)
2026년 12월 1일
연구 완료 (추정된)
2026년 12월 1일
연구 등록 날짜
최초 제출
2026년 7월 28일
QC 기준을 충족하는 최초 제출
2026년 8월 18일
처음 게시됨 (실제)
2026년 8월 19일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 8월 19일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 18일
마지막으로 확인됨
2026년 8월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- Currently in submission
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .