Relaxation Intervention in Patients With Diabetic Foot Ulcer: A Pilot Randomized Controlled Trial With a Nested Qualitative Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 4
- 主要终点
- Rate of adherence to the study protocol
研究概览
简要总结
Diabetic foot ulcers (DFU) are one of the most serious complications of diabetes and can lead to amputations in 85% of cases, resulting in physical, psychological, family, social and economic consequences. Psychological interventions can contribute to the improvement of wound healing and, relaxation, in particular, seems to contribute to faster wound healing. More research is needed to assess the effectiveness of different types of intervention on different types of wounds, in particular on chronic wounds such as DFU.
This is a Pilot Randomised Controlled Study of a Psychological Intervention that aims to evaluate the feasibility and acceptability of a muscle relaxation intervention with guided imagery (experimental group - EG) compared to a neutral guided imagery placebo (active control group - ACG) and a group that does not receive any psychological intervention (passive control group - PCG), to inform a future definitive Randomised Controlled Study (RCT) that tests its effectiveness. This study will also examine, qualitatively, the perspectives of patients with DFU on the relaxation intervention, in order to check its acceptability and applicability; as well as the perspectives of health professionals on this adjuvant therapy, its applicability and integration into the care system of multidisciplinary diabetic foot consultations.
Participants have a diagnosis of Diabetes Mellitus and Diabetic Foot; one or two chronic ulcers active at the time of assessment; and clinical levels of stress or anxiety or depression. Participants will be randomized by the three conditions - EG, ACG and PCG - and assessed on the day of the first consultation or nursing treatment for chronic DFU (T0), two months later (T1), and six months later (T2; follow-up). Two weeks after T1, an interview will be conducted with patients with DFU that benefited from the relaxation sessions and to the health professionals who provided them the DFU care.
The results of the present study will contribute for a better understanding of DFU progression, healing, prevention of re-ulceration and future amputations and, consequently, for the improvement of patients' quality of life.
详细描述
General Aims:
This pilot RCT aims to assess the feasibility and acceptability of a muscle relaxation intervention with guided imagery (experimental group - GE) compared to a neutral guided imagery placebo (active control group - ACG) and a group that does not receive any psychological intervention (passive control group - PCG), prior to the implementation of a future definitive RCT that will assess its effectiveness.
This study will also examine, qualitatively, the perspectives of patients with DFU regarding the relaxation intervention, in order to check its acceptability and applicability; as well as the perspectives of health professionals on this adjuvant therapy, its applicability and integration into the multidisciplinary team of diabetic foot consultations.
Pilot RCT specific aims:
- To evaluate the rates of eligibility, recruitment and adherence to the study protocol, participation in follow-up, and withdrawal. The degree of patient satisfaction with the relaxation intervention will also be assessed.
- To verify the feasibility of the assessment protocol and to obtain preliminary estimates of the effects of the intervention on health outcome measures (degree of DFU healing, DFU-related quality of life, anxiety, depression and stress, DFU representations and physical and mental quality of life);
- Synthesize the information to estimate the sample size required for a future definitive RCT.
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 (Participant, Outcomes Assessor)
盲法说明
Eligible participants will be randomised into the three groups into blocks of variable size, multiples of three; and will be stratified according to: i) data collection site; ii) Chronic Renal Disease; and iii) Peripheral Arterial Disease; because they are factors of poor prognosis in the DFU healing (Ferreira et al., 2014). This procedure will be performed using an online random number generator, by a researcher external to the team involved in the implementation of this study, in order to ensure the concealment of the allocation of participants by the various groups (Pandis, 2012). After this procedure, it will not be possible to conceal the group to which the patient belongs from the researcher who will perform the psychological intervention. However, health professionals (doctors and nurses) will be blinded during the entire procedure, because they fill in the RESVECH 2.0, which assesses the DFU healing.
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
- •Diabetes Mellitus diagnosis;
- •Diagnosis of Diabetic Foot;
- •Having one or two active chronic ulcers (> 6 weeks) at the time of the assessment;
- •Being followed at the Multidisciplinary Consultation of the Diabetic Foot from the Centro Hospitalar Universitário do Porto (CHUP), at the Diabetic Foot Clinic from the Centro Hospitalar do Tâmega e Sousa (CHTS) and from the Hospital de Braga;
- •Presenting clinical levels of stress (scores greater than 13 for males and greater than 17 for females on the Perceived Stress Scale) or anxiety or depression (scores greater than 11 on Hospital Anxiety and Depression Scale).
排除标准
- •The active DFU at the time of the assessment being a relapse;
- •Having more than two DFU currently active;
- •Being on hemodialysis treatment;
- •Presence of psychosis or dementia described in the patient's medical record;
- •Having cancer disease;
- •Having undergone a transplant;
- •Receiving psychological counselling at the time of the assessment.
- •For the qualitative study nested in the Pilot RCT, participants must meet the same inclusion and exclusion criteria defined above, plus being allocated to the EG and have completed the four intervention sessions. From those participants, the following cases will be selected:
- •Three typical cases of patients with neuropathic foot defined by the presence of neuropathic pain (e.g., heat, tingling, electrical shock), presence of distal pulses by palpation, and loss of protective sensitivity;
- •Three typical cases of patients with neuroischemic foot defined by the presence of peripheral artery disease, intense-variable pain, absence of distal pulses by palpation, and variable protective sensitivity.
结局指标
主要结局
Rate of adherence to the study protocol
时间窗: Through study completion, an average of 6 months
This rate will result from the proportion between the number of patients who performed the assessments/intervention sessions and the number of patients who completed the baseline assessment (T0), in percentage.
Rate of eligibility
时间窗: Baseline (T0)
This rate will result from the proportion between the number of eligible patients and the total number of observed patients, in percentage.
Patient satisfaction with the relaxation intervention
时间窗: End of intervention/ 2 months later at post-test (T1)
The degree of patients´ satisfaction with the relaxation intervention will be assessed through questions developed for this purpose, including the degree of general satisfaction with the sessions; the impact on stress, anxiety and depression, and wound healing after the four sessions; the degree of usefulness for patients with DFU; the desire to participate in future sessions; and the recommendation of the sessions to other patients with DFU. All the questions will be assessed on a Likert scale from 1 (very unsatisfied/ none/ totally disagree) to 5 (very satisfied/ extreme/ totally agree).
Rate of recruitment
时间窗: Baseline (T0)
This rate will result from the proportion between the number of patients who accepted to participate and the number of eligible patients, in percentage.
Rate of refusal
时间窗: Baseline (T0)
This rate will result from the proportion between the number of patients who rejected to participate in the study and the number of patients invited to participate, in percentage.
Rate of participation in follow-up
时间窗: Through study completion, an average of 6 months
This rate will result from the proportion between the number of patients who participated in follow-up assessment and the number of patients who completed the baseline assessment (T0), presented in percentage.
Rate of dropout
时间窗: Through study completion, an average of 6 months
This rate will result from the proportion between the number of patients who dropout the study and the number of patients who completed the baseline assessment (T0), presented in percentage.
次要结局
- Degree of DFU healing(Changes from baseline (T0) to the end of intervention/ 2 months later at post-test (T1), and after a six month follow-up (T2))
- Anxiety symptoms(Changes from baseline (T0) to the end of intervention/ 2 months later at post-test (T1), and after a six month follow-up (T2))
- Depression symptoms(Changes from baseline (T0) to the end of intervention/ 2 months later at post-test (T1), and after a six month follow-up (T2))
- Impact of DFU on patients' Quality of Life(Changes from baseline (T0) to the end of intervention/ 2 months later at post-test (T1), and after a six month follow-up (T2))
- Diastolic Pressure(Before and after each intervention (EG) or placebo (ACG) at 2 weeks (1st Session), 4 weeks (2nd Session), 6 weeks (3rd Session) and 8 weeks (4th Session), after the baseline (T0))
- Adherence to DFU Care(Changes from baseline (T0) to the end of intervention/ 2 months later at post-test (T1), and after a six month follow-up (T2))
- Representations regarding the DFU(Changes from baseline (T0) to the end of intervention/ 2 months later at post-test (T1), and after a six month follow-up (T2))
- Heart rate(Before and after each intervention (EG) or placebo (ACG) at 2 weeks (1st Session), 4 weeks (2nd Session), 6 weeks (3rd Session) and 8 weeks (4th Session), after the baseline (T0))
- Physical Quality of Life(Changes from baseline (T0) to the end of intervention/ 2 months later at post-test (T1), and after a six month follow-up (T2))
- Mental Quality of Life(Changes from baseline (T0) to the end of intervention/ 2 months later at post-test (T1), and after a six month follow-up (T2))
- Perceived Stress(Changes from baseline (T0) to the end of intervention/ 2 months later at post-test (T1), and after a six month follow-up (T2))
- Emotional Distress(Changes from baseline (T0) to the end of intervention/ 2 months later at post-test (T1), and after a six month follow-up (T2))
- Systolic Pressure(Before and after each intervention (EG) or placebo (ACG) at 2 weeks (1st Session), 4 weeks (2nd Session), 6 weeks (3rd Session) and 8 weeks (4th Session), after the baseline (T0))
研究者
Gabriela Ferreira
Master in Health Psychology
University of Minho