The Effect of Mobile-Based Education on Caregiver Burden, Coping With Stress, and Prevention of Pressure Injuries in Bedridden Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Change in Caregiver Burden Assessed by Zarit Caregiver Burden Interview (ZCBI) Score
研究概览
简要总结
This study is a randomized controlled trial designed to evaluate the effectiveness of a nurse-led, mobile health (mHealth) education program for informal caregivers of bedridden patients receiving home healthcare services. The intervention, named the "Mobile Life Without Pressure Injury" application, is theoretically grounded in the Health Belief Model (HBM). The primary objective is to assess the impact of this mobile-based education on three key outcomes: (1) the prevention and risk reduction of pressure injuries in bedridden patients, (2) the level of caregiver burden experienced by primary caregivers, and (3) the coping styles used by caregivers to manage stress.
Background:
Bedridden patients are at high risk for developing pressure injuries, a largely preventable complication that causes significant pain, morbidity, and healthcare costs. The responsibility for daily care often falls on informal family caregivers. These caregivers frequently lack formal training in pressure injury prevention, which can lead to increased psychological stress, feelings of helplessness, and a heavy caregiver burden. While mobile health applications offer a promising channel for accessible education, there is a need for theoretically-driven interventions that target not just knowledge, but also behavioral change and caregiver well-being over the long term.
Study Design and Methods:
This six-month, parallel-group, randomized controlled trial enrolled 60 patient-caregiver pairs (dyads) from the Home Health Services unit of Balıkesir Atatürk City Hospital in Turkey. Patients were bedridden, free of existing pressure injuries, and assessed as being at low or medium risk according to the Braden Scale. Caregivers were primary informal caregivers who owned a smartphone and had not previously received structured pressure injury prevention education.
Participants were randomly assigned using a stratified block randomization method (based on patient risk level and caregiver age) to either the intervention group (n=30) or the control group (n=30).
Intervention Group: Caregivers received access to the "Mobile Life Without Pressure Injury" application for six months. The app includes educational modules, daily care tracking, reminder notifications (cues to action), and an "Ask the Expert" feature for direct communication with the research nurse. The educational content was specifically designed to address the components of the Health Belief Model (perceived susceptibility, severity, benefits, barriers, and self-efficacy).
Control Group: Caregivers and patients continued to receive standard, routine home healthcare services as defined by national regulations, without any additional structured education or mobile application support.
Data were collected through face-to-face home visits at four time points: baseline (pretest), 1st month, 3rd month, and 6th month (posttest). Data collection instruments included a Patient and Caregiver Identification Form, the Braden Scale for Predicting Pressure Sore Risk, the Pressure Injury Assessment Form, the Zarit Caregiver Burden Interview (ZCBI), and the Ways of Coping Inventory (WCI).
Outcome Measures:
Primary Outcomes: Change in Zarit Caregiver Burden Interview (ZCBI) scores over six months; change in coping styles (Ways of Coping Inventory subscales) over six months.
Secondary Outcomes: Incidence of new pressure injuries in patients; change in Braden Scale risk scores over six months; caregiver satisfaction and perceived utility of the mobile application.
Statistical Analysis:
The primary analysis will evaluate the group x time interaction using repeated measures analysis of variance (ANOVA) or Generalized Estimating Equations (GEE), depending on the distribution of the data. The analyses will follow the intention-to-treat principle. A post-hoc power analysis will be conducted to confirm the achieved statistical power based on the final sample size.
Hypothesis:
The investigators hypothesize that, compared to caregivers in the control group, caregivers in the intervention group will demonstrate significantly reduced caregiver burden, increased use of active coping strategies, and decreased use of passive coping strategies over the six-month study period. Furthermore, it is hypothesized that patients in the intervention group will exhibit a lower incidence of pressure injuries and improved (higher) Braden Scale scores compared to the control group.
Implications:
This study aims to provide robust evidence on the efficacy of a theory-based mobile health intervention for supporting informal caregivers. If proven effective, the "Mobile Life Without Pressure Injury" application could serve as a scalable, cost-effective, and accessible model for integrating digital health tools into home healthcare nursing practice to improve both patient safety and caregiver well-being.
详细描述
Study Design and Methodology
This investigation is a single-center, two-arm, parallel-group, randomized controlled superiority trial with a six-month follow-up period. The study employs a stratified block randomization design to ensure balanced allocation of participants across intervention and control groups. The trial protocol was developed in accordance with the CONSORT 2010 Statement guidelines for reporting parallel group randomized trials.
Theoretical Framework: Health Belief Model
The educational content and delivery mechanisms of the intervention are explicitly grounded in the Health Belief Model (HBM), a well-established theoretical framework for understanding and promoting health-related behavior change. The HBM posits that an individual's likelihood of adopting a preventive health behavior is influenced by six core constructs: (1) Perceived Susceptibility (belief about the likelihood of experiencing a health problem), (2) Perceived Severity (belief about the seriousness of the condition and its consequences), (3) Perceived Benefits (belief in the efficacy of the advised action to reduce risk or severity), (4) Perceived Barriers (belief about the tangible and psychological costs of the advised action), (5) Self-Efficacy (confidence in one's ability to successfully perform the required action), and (6) Cues to Action (internal or external triggers that stimulate the decision-making process).
The "Mobile Life Without Pressure Injury" application was systematically designed to address each of these constructs. Educational modules enhance perceived susceptibility and severity by detailing risk factors and the clinical and economic consequences of pressure injuries. The modules also emphasize perceived benefits by demonstrating how simple, consistent care practices (e.g., regular repositioning, skin inspection) can effectively prevent tissue damage. Practical, step-by-step video and pictorial guides aim to lower perceived barriers related to lack of knowledge or physical difficulty. The application's interactive features, including self-assessment quizzes and positive reinforcement messages, are designed to bolster caregiver self-efficacy. Finally, weekly push notifications serve as potent cues to action, reminding caregivers to perform key preventive behaviors such as skin checks and patient repositioning.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
This is an open-label study due to the nature of the behavioral/mHealth intervention; participants and the principal investigator are aware of group assignment. However, the statistician performing the final data analyses will be blinded to group allocation (groups coded as A and B).
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
- •For Bedridden Patients:
- •Aged 18 years or older
- •Confirmed bedridden status (complete or near-complete immobility requiring assistance for all activities of daily living)
- •Absence of any existing pressure injury at the time of enrollment, as confirmed by full skin assessment using the NPIAP staging system
- •Braden Scale score in the "low risk" category (15-18 points; 15-16 for patients ≥75 years) or "medium risk" category (13-14 points)
- •No medical contraindication to routine repositioning, as verified by the Home Health Services unit physician
- •Provision of informed consent (by patient or legally authorized representative)
- •For Primary Caregivers:
- •Aged 18 years or older
- •Identified as the primary informal caregiver responsible for the majority of the patient's daily care activities
- •Minimum educational level of primary school completion
- •Ownership of a personal smartphone with an active internet connection
- •No prior participation in a structured, formal education program on pressure injury prevention
- •Willingness and ability to use a mobile application for the entire six-month study duration
- •Provision of written informed consent
排除标准
- •Development of a medical condition in the patient that contraindicates repositioning
- •Patient has an underlying immunosuppressive condition (e.g., uncontrolled diabetes with HbA1c >9%, active oncologic disease undergoing chemotherapy/radiotherapy, end-stage renal disease requiring dialysis, liver cirrhosis)
- •Change in the designated primary caregiver during the six-month follow-up period
- •Caregiver has a physical or cognitive impairment precluding use of the mobile application or completion of questionnaires
- •Hospital admission of the patient exceeding 7 consecutive days
研究组 & 干预措施
Mobile Health Education for Pressure Injury Prevention
Caregivers in this arm continue to receive standard home healthcare services provided by the Balıkesir Atatürk City Hospital Home Health Services unit. Routine care includes periodic nursing and physician home visits for patient assessment, monitoring, wound care, prescription management, and general health education. No structured pressure injury prevention education or mobile application support is provided. Data are collected at baseline, 1st, 3rd, and 6th months during home visits.
干预措施: Mobile Life Without Pressure Injury Application (Behavioral)
Control: Standard Home Healthcare
Caregivers in this arm continue to receive standard home healthcare services provided by the Balıkesir Atatürk City Hospital Home Health Services unit. Routine care includes periodic nursing and physician home visits for patient assessment, monitoring, wound care, prescription management, and general health education. No structured pressure injury prevention education or mobile application support is provided. Data are collected at baseline, 1st, 3rd, and 6th months during home visits
结局指标
主要结局
Change in Caregiver Burden Assessed by Zarit Caregiver Burden Interview (ZCBI) Score
时间窗: Baseline (T0), Month 1 (T1), Month 3 (T2), Month 6 (T3)
The Zarit Caregiver Burden Interview (ZCBI) is a 22-item self-report instrument used to measure the subjective burden experienced by informal caregivers. Each item is rated on a 5-point Likert scale (0 = Never to 4 = Nearly Always). Total scores range from 0 to 88, with higher scores indicating greater perceived burden. The validated Turkish version of the ZCBI is used. Change in total ZCBI score will be evaluated across the four measurement time points.
Change in Coping Styles Assessed by Ways of Coping Inventory (WCI) Subscale Scores
时间窗: Baseline (T0), Month 1 (T1), Month 3 (T2), Month 6 (T3)
The Ways of Coping Inventory (WCI) is a 30-item self-report instrument used to assess coping strategies employed when facing stressful situations. The validated Turkish adaptation yields scores for five distinct subscales: Self-Confident Approach, Optimistic Approach, Seeking Social Support, Helpless Approach, and Submissive Approach. Each item is rated on a 4-point Likert scale (0 = Not at all appropriate to 3 = Very appropriate). Changes in each subscale score will be evaluated across the four measurement time points.
次要结局
未报告次要终点
研究者
Gündem Yakan Şahin
Principal Investigator
Ege University