Implementing a Contextually Appropriate Intervention Strategy in Primary Care for the Foot-ankle of People With Diabetes to Improve Clinical and Functional Status and Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 356
- 试验地点
- 1
- 主要终点
- Change From Baseline of the Foot and Ankle range of motion at 12-week
研究概览
简要总结
The main objective of this type 2 hybrid implementation effectiveness trial is to implement a contextually appropriate preventive intervention for 12 weeks face to face group foot and ankle exercises for people with diabetic foot in the primary care of the city of Limeira/SP, through the training of Primary Care workers. The study will monitor the implementation itself and the clinical outcomes: clinical and functional status and quality of life.
详细描述
The study is a type 2 hybrid implementation effectiveness trial, whose objective is to simultaneously test the clinical intervention and the implementation strategy. The study will take place in 4 phases, the first being pre-implementation, whose objective is to gather information about local characteristics, barriers and facilitators, and constitute the implementation team. During the second phase, the implementation team will be responsible for structuring the actions for the implementation of the intervention, adapting it to the context defined in phase 1, developing strategies for the training of primary care workers. In phase 3, we will implement the intervention either using a software or a booklet for people with diabetes and we will monitor the participants' diabetes-related, functional and quality of life outcomes after the 12 weeks of intervention. Reach, adoption and implementation will be evaluated using the RE-AIM tool. In phase 4 - _maintenance - _the municipality will be responsible for maintaining, expanding and improving the changes achieved, promoting the sharing of experience with other public and private institutions, facilitating the diffusion of similar programs. Specifically in the phase 3, a randomized controlled trial will be performed with 356 patients with diabetic neuropathy. The participants will be randomly assigned into either a control group (recommended foot care by international consensus with no foot exercises) or an intervention group that will perform face to face exercises, supervised by physiotherapists for 12-weeks. The subjects will be evaluated in 2 different times to access the effect of the intervention: baseline and 12 weeks, for all outcomes. The following outcomes will be assessed in all times: (1) diabetic neuropathy symptoms by Michigan Neuropathy Screening Instrument, (2) range of motion of the ankle and first metatarsophalangeal joint, (3) fuzzy score of the neuropathy severity, (4) Time up and go, (5) hallux and toes strength (by a pressure plate measurement , (6) hallux strength (by the enhanced paper grip test),(7) ulcers and pre-ulcerative lesions and (8) quality of life (EQ-5D). The hypothesis of this study is that the intervention will reduce the symptoms of diabetic neuropathy, increase the strength of the foot muscles, decrease the severity of the diabetic neuropathy (fuzzy score), decrease the number of neuropathy symptoms, as well increase range of motion, functionality and quality of life.
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
- Double (Investigator, 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
- •Adults of both sexes;
- •Diabetes mellitus type 1 or 2;
- •Residence within the catchment area of the Family Health Units.
- •Availability to participate in the intervention at the established group time.
- •Non-inclusion Criteria:
- •Clinical diagnosis of dementia;
- •Inability to provide reliable and consistent information;
- •Perform physiotherapy intervention throughout the intervention period;
- •Active foot ulcer or major vascular complications.
排除标准
- 未提供
研究组 & 干预措施
Intervention group
Patients in the intervention group will perform face to face foot-related exercises for 12 weeks.
干预措施: Foot-related exercises (Other)
Control group
Participants in the control group will not receive any specific intervention in addition to the treatment recommended by the health professionals team (doctors, nurses, podiatrists), which includes pharmacological treatment, and self-care recommendations and foot care by international consensus.
结局指标
主要结局
Change From Baseline of the Foot and Ankle range of motion at 12-week
时间窗: 12 weeks
Ankle and first metatarsophalangeal joint will be measured by manual goniometers.
Change From Baseline Diabetic Neuropathy Symptoms at 12-week Instrument
时间窗: 12 weeks
Score of the Michigan Neuropathy Screening Instrument (MNSI). This questionnaire comprises 15 questions about symptoms and events related to leg and foot sensitivity and is administered by the participant himself. The answers are summed to get a total score. The sum of all items results in a score ranging from 0 to 13 (13 represents the worst rating of the neuropathy)
次要结局
- Change From Baseline in Disability at 12-Week Instrument(12 WEEKS)
- Healthcare Resource Utilization and Direct/Indirect Costs(12 WEEKS)
- Change from baseline of the hallux strength at 12-week(12 weeks)
- Change From Baseline of the foot ulcers and pre ulcerative lesions at 12-week(12 weeks)
- Change From Baseline of the Fuzzy Classification of the Diabetic Neuropathy Severity at 12-week(12 weeks)
- Change from baseline of the toes and hallux strength at 12-week(12 weeks)
- Change From Baseline Time up and go at 12-week(12 weeks)
- Change from baseline of the Quality of life at 12-week(12 weeks)
- Reach of the implementation at 12-week(12 weeks)
- Adoption of the implementation(End of phase 1, end of phase 2)
- Implementation at 12 weeks(12 weeks)
研究者
Isabel de Camargo Neves Sacco
Associate Professor
University of Sao Paulo General Hospital