Effect of a Self-management Telehealth Program on Improving Strength and Hand Function in Systemic Sclerosis Patients: a Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Hand grip strength
研究概览
简要总结
Scleroderma causes the skin on the hands to harden, causing the hands to contract, and the fingers to bend abnormally, which affect the patient's work and quality of life.
This project aims to test the effect of a self-management telehealth program. The goal of this clinical trial is to improving hand strength and function in SSc patients.
Participants will: randomly into 3 groups; a) usual education, b) watching 3.27-minute video guide as needed adding on usual education, c) watching video guide and weekly telephone notifications adding to usual education.
A physical therapist coached home program for self-hand and joint exercise, a nursing coach home routine hand care.
Visit the clinic with a diary at 6 weeks after program for checkups and tests
Researchers will compare hand strength and function, self-management behavior, HAMIS scores, hand grip strength (HGS), and quality of life (QoL) between groups, as well as the changes in these parameters at week 6 compared to baseline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
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
- •Adult SSc patients who met the 2013 classification criteria of the American College of Rheumatology/European Alliance of Associations for Rheumatology and fulfilled all of the following criteria were included:
- •Ability to communicate in the Thai language
- •Stable disease
- •Hand involvement defined as a hand mobility in scleroderma score ≥1 or a limited range of motion in at least one hand joint
- •Ownership of a smartphone capable of recording video clips
- •Ability to access videos on their smartphone independently
排除标准
- •Severe contracture deformity of the hands (defined as a hand mobility in scleroderma score of 27)
- •Impaired hand sensation; cognitive, hearing, or visual impairment; or physical limitations (e.g., paralysis, muscle weakness)
- •Scheduled surgery involving the hand, eyes, or ears; or required hospitalization within the past 6 weeks
- •Presence of infected wounds or active inflammation on the hand, wrist, or fingers that prevents performance of hand exercises
研究组 & 干预措施
usual education
An usual education included self-management booklet that developed based on the self-management framework consisting of 4 categories: a) self-monitoring, which consisted of self-observation and self-recording of DU and RP; b) performing special tasks to manage the disease, including keeping warm, maintaining moisture, and taking traumatic wound precautions; c) information seeking; and d) self-adjustment based on disease activity and treatment.
干预措施: self-management program (Behavioral)
Video guide and usual education
Video guide add on usual education was the hand and joint exercise video guide that included a 3.27-minute educational video on 6 basic daily hand exercises including: a) stretching wrist flexion and extension, b) range of motion (ROM) ulnar and radial deviation, c) ROM finger abduction and adduction, d) finger pincer, e) finger flexion and extension, and f) finger grab.
干预措施: Video guide and usual education (Behavioral)
Telephone notification, video guide and usual education
Telephone notifications consisted of weekly calls for further continuity and engagement with hand exercises. Each call lasted about 10 minutes, providing problem-solving support, knowledge reinforcement, and motivation to encourage adherence to the program.
干预措施: Telephone notification, video guide and usual education (Behavioral)
结局指标
主要结局
Hand grip strength
时间窗: 6 weeks
次要结局
- Visual analog scale of Quality of life(6 weeks)
- Hand mobility in scleroderma score(6 weeks)
- Self-management behavior score(6 weeks)
研究者
Orathai Wantha
Registered Nurse
Khon Kaen University