Clinical Research Directory

Mobile Education for Pressure Injury Prevention and Caregiver Support

Sponsor: Gündem Yakan Şahin

Summary

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.

Official title: The Effect of Mobile-Based Education on Caregiver Burden, Coping With Stress, and Prevention of Pressure Injuries in Bedridden Patients

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