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.

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.

Study Setting and Recruitment

The study is being conducted at the Home Health Services (HHS) unit of Balıkesir Atatürk City Hospital, a tertiary care facility in Balıkesir Province, Turkey. This unit provides multidisciplinary in-home medical care, nursing services, and rehabilitation to approximately 1,635 registered bedridden patients with chronic and disabling conditions.

Recruitment commenced in June 2025 and continued until the target sample size was achieved. The HHS unit's electronic patient registry was screened by the principal investigator to identify potentially eligible patient-caregiver dyads. An initial telephone contact was made with the primary caregivers of these patients. During this call, the investigator provided a brief overview of the study's purpose, the voluntary nature of participation, and the expected time commitment. Caregivers who expressed interest in participating were scheduled for a baseline home visit to confirm final eligibility and obtain written informed consent.

Eligibility Criteria

The inclusion and exclusion criteria are applied at the level of the patient-caregiver dyad. Both the patient and the primary caregiver must meet all applicable criteria for the dyad to be enrolled.

Inclusion Criteria for Bedridden Patients:

Aged 18 years or older.

Confirmed bedridden status (complete or near-complete immobility).

Absence of any existing pressure injury at the time of enrollment, as confirmed by full skin assessment conducted by the research nurse using the National Pressure Injury Advisory Panel (NPIAP) staging system.

Braden Scale for Predicting Pressure Sore Risk score in the "low risk" (15-18 points, or 15-16 points for patients over 75 years of age) or "medium risk" (13-14 points) categories.

No medical contraindication to routine repositioning (as verified by the HHS unit physician).

Provision of informed consent (by the patient directly if capable, or by their legally authorized representative/primary caregiver if the patient lacks decision-making capacity).

Inclusion Criteria for Primary Caregivers:

Identified as the primary informal caregiver responsible for the majority of the patient's daily care activities (e.g., hygiene, feeding, positioning).

Aged 18 years or older.

Minimum educational level of primary school completion (to ensure basic literacy for interacting with the mobile application and study questionnaires).

Ownership of a personal smartphone with an active internet connection (Wi-Fi or mobile data).

No prior participation in a structured, formal education program specifically focused on pressure injury prevention.

Willingness and ability to use a mobile application on their personal device for the six-month study duration.

Provision of written informed consent.

Exclusion Criteria:

Development of a medical condition in the patient during the study period that contraindicates repositioning.

Patient has an underlying immunosuppressive condition that could independently alter tissue integrity and wound healing (e.g., uncontrolled diabetes mellitus, active oncologic disease, end-stage renal disease, liver cirrhosis).

A change in the designated primary caregiver during the six-month follow-up period.

The caregiver has a physical or cognitive impairment (e.g., severe uncorrected visual deficit, advanced dementia) that precludes their ability to use the mobile application or complete the study questionnaires.

Hospital admission of the patient exceeding 7 days, as this would remove the caregiver's primary responsibility for pressure injury prevention for a significant portion of the study period (note: hospital-acquired pressure injuries are tracked but analyzed separately).

Randomization and Allocation Concealment

A stratified block randomization procedure was implemented to minimize selection bias and ensure baseline comparability between the intervention and control groups on key prognostic factors.

Stratification: Eligible patient-caregiver dyads were first stratified into two strata based on the patient's baseline Braden Scale risk category: Stratum 1 (Low Risk) and Stratum 2 (Medium Risk).

Blocking: Within each risk stratum, participants were further blocked by caregiver age group (≤40 years, 41-60 years, ≥61 years) to control for the potential confounding effect of caregiver age on technology use and baseline stress levels.

Sequence Generation: Separate computer-generated random allocation sequences (using a random number generator) were created by an independent statistician who was not involved in participant recruitment or data collection. A block size of 4 was used within each stratum-age combination to ensure balanced assignment over time.

Allocation Concealment: The randomization sequence was concealed in sequentially numbered, opaque, sealed envelopes. The envelope for a given dyad was only opened by the principal investigator after the dyad had been definitively enrolled in the study and all baseline assessments had been completed. This procedure ensured that allocation was concealed until the moment of assignment.

Given the nature of the intervention (use of a mobile application), blinding of participants and the principal investigator to group assignment was not feasible after randomization. However, the data analyst responsible for conducting the final statistical analyses will be blinded to group allocation (coded as Group A and Group B) to ensure objectivity.

Intervention: The "Mobile Life Without Pressure Injury" Application

The intervention consists of a six-month, self-directed educational program delivered via a custom-developed mobile application ("Mobile Life Without Pressure Injury") installed on the caregiver's personal smartphone. The application was developed in collaboration with a professional software development firm (NM Yazılım, Kastamonu Teknokent) based on specifications and educational content created by the research team.

Application Development and Content Validation:

Content Creation: Educational content (text, images, video scripts) was developed by the research team based on a comprehensive review of the literature and the 2019 International Clinical Practice Guideline for Prevention and Treatment of Pressure Ulcers/Injuries (NPIAP/EPUAP/PPPIA).

Expert Review: The initial content and application wireframes were reviewed by a panel of six independent experts in the fields of public health nursing, wound care, and health education. Feedback was incorporated to refine the content for accuracy, clarity, and pedagogical effectiveness.

Pilot Testing: A pilot study was conducted with five caregiver-patient dyads who met all eligibility criteria but were not part of the main study sample. The pilot evaluated the application's functionality, usability, and acceptability over a two-week period. Based on pilot feedback, adjustments were made to font sizes, notification sounds, and the navigation flow of the interface.

Application Features and Functionality:

Following installation, the principal investigator provided a standardized, face-to-face training session for each caregiver in the intervention group, demonstrating all features of the application using a demonstration prototype. The application includes five core modules:

Education Module: This module contains multimedia content (illustrated text, short instructional videos, and infographics) organized into chapters that mirror the HBM constructs. Topics include the definition and stages of pressure injuries, identification of individual risk factors, consequences of untreated pressure injuries (clinical and economic burden), and a detailed guide to evidence-based prevention strategies (repositioning techniques, use of support surfaces, skin care, nutrition).

Assessment Module: A quiz feature allows caregivers to self-assess their understanding of the educational content. The multiple-choice questions are framed to reinforce key concepts from the HBM, such as recognizing risk factors (susceptibility) and identifying effective preventive actions (benefits). Immediate feedback is provided for each answer.

Daily Care Tracking Module: Caregivers are prompted to log the completion of daily preventive care activities, such as performing a full skin inspection and repositioning the patient. This feature serves to enhance self-efficacy by providing a tangible record of their adherence and effort.

Notification Module: The research team sends standardized, evidence-based push notifications to the caregiver's phone once per week. The content of these messages rotates weekly and is explicitly designed to serve as a "cue to action," reinforcing a specific HBM construct (e.g., a message about the difficulty of treating advanced wounds reinforces perceived severity; a message praising their efforts reinforces self-efficacy).

"Ask the Expert" Module: This feature provides a secure, text-based communication channel allowing the caregiver to send non-urgent questions directly to the principal investigator. This was designed to reduce perceived barriers by providing timely, professional support and guidance, thereby mitigating feelings of isolation and uncertainty.

Control Group: Standard Home Healthcare

Participants assigned to the control group will continue to receive the standard, routine home healthcare services provided by the Balıkesir Atatürk City Hospital HHS unit. These services are defined by the Turkish Ministry of Health's "Regulation on the Provision of Home Healthcare Services" and include periodic in-home nursing and physician visits for assessment, monitoring, wound care (if applicable), prescription management, and general health education. During the six-month study period, control group participants will not receive the "Mobile Life Without Pressure Injury" application, nor will they be offered any additional structured education on pressure injury prevention beyond what is normally provided during routine HHS visits.

Data Collection Procedures and Instruments

All study data are collected by the principal investigator during scheduled home visits at four time points for both groups: Baseline (T0, immediately following enrollment), 1st Month Follow-up (T1), 3rd Month Follow-up (T2), and 6th Month Follow-up (T3). Each data collection visit lasts approximately 30-45 minutes.

Patient-Level Instruments:

Patient Identification Form: A 10-item investigator-developed form to collect sociodemographic data (age, sex, education) and clinical history related to bedridden status (etiology, duration of immobility, comorbidities).

Braden Scale for Predicting Pressure Sore Risk: A widely validated, 6-item scale that assesses risk across six subscales: sensory perception, moisture, activity, mobility, nutrition, and friction/shear. Total scores range from 6 to 23, with lower scores indicating higher risk. This scale is administered at all four time points.

Pressure Injury Assessment Form: An investigator-developed form used to systematically document any newly developed pressure injury during the study period. It records the date of onset, number of injuries, anatomical location, and stage according to the NPIAP classification system.

Caregiver-Level Instruments:

Caregiver Identification Form: A 17-item investigator-developed form to collect sociodemographic data (age, sex, education, relationship to patient), employment status, and details of the caregiving context (duration of caregiving, daily hours of care, presence of other helpers).

Zarit Caregiver Burden Interview (ZCBI): A 22-item, self-report instrument used to measure the subjective burden experienced by 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 representing greater perceived burden. The validated Turkish version of the ZCBI is used.

Ways of Coping Inventory (WCI): A 30-item, self-report instrument used to assess the coping strategies employed by individuals when facing stressful situations. The Turkish adaptation of the WCI 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).

Process Data for Intervention Group:

Application Usage Analytics: De-identified usage data are collected from the application's backend server. Metrics include the number of logins, frequency and duration of engagement with the Education and Quiz modules, number of entries logged in the Daily Care Tracker, and number of messages sent via the "Ask the Expert" feature.

Caregiver Satisfaction Survey: At the final (T3) follow-up visit, caregivers in the intervention group are asked a single-item question to rate the perceived overall utility of the mobile application on a 4-point scale (1 = Not at all useful, 2 = Somewhat useful, 3 = Quite useful, 4 = Very useful).

Sample Size and Statistical Power

The required sample size was determined a priori using G*Power software (Version 3.1.9.7). The calculation was based on the primary outcome of caregiver burden (Zarit Caregiver Burden Interview score). Using an effect size (Cohen's d) of 1.08, which was derived from a previous similar study in the Turkish home care context, an alpha level of 0.05, and a desired statistical power of 0.95, the minimum required sample size was calculated to be 24 participants per group (total N=48). To account for an anticipated attrition rate of up to 20% over the six-month follow-up period, the recruitment target was set at 30 participants per group, for a total enrollment of 60 patient-caregiver dyads. A post-hoc power analysis will be performed based on the final number of participants completing the T3 assessment.

Data Analysis Plan

Quantitative data will be analyzed using IBM SPSS Statistics (Version 22.0). A two-tailed p-value of less than 0.05 will be considered the threshold for statistical significance. All analyses will be conducted with 95% confidence intervals.

Descriptive Statistics: Baseline sociodemographic and clinical characteristics of the intervention and control groups will be summarized using means and standard deviations (for normally distributed continuous variables), medians and interquartile ranges (for non-normally distributed continuous variables), and frequencies and percentages (for categorical variables).

Baseline Comparability: The success of the randomization process will be assessed by comparing baseline characteristics between the two groups. Independent samples t-tests (or Mann-Whitney U tests) will be used for continuous variables, and Chi-square tests (or Fisher's Exact Test) will be used for categorical variables.

Primary Outcome Analysis (Intervention Effectiveness): The primary analytical approach for evaluating the effect of the intervention on caregiver burden and coping styles will be a two-way mixed-design analysis of variance (ANOVA) or a Generalized Estimating Equation (GEE) model, depending on the distributional properties of the data. The model will include Group (Intervention vs. Control) as the between-subjects factor, Time (T0, T1, T2, T3) as the within-subjects factor, and the Group × Time interaction term. A statistically significant interaction effect will indicate that the pattern of change over time differs between the two groups, thereby supporting the efficacy of the intervention. If a significant interaction is found, post-hoc tests with Bonferroni correction will be conducted to identify the specific time points at which the groups diverge.

Secondary Outcome Analysis:

The incidence of new pressure injuries in the intervention and control groups will be compared using the Chi-square test (or Fisher's Exact Test).

Changes in Braden Scale scores over time will be analyzed using the same mixed-model approach described for the primary outcomes.

Sensitivity and Subgroup Analyses: A per-protocol analysis may be performed as a sensitivity analysis to assess the robustness of the findings. Subgroup analyses may be conducted to explore whether the intervention effect on caregiver burden is modified by key baseline characteristics such as caregiver age, relationship to the patient, or baseline risk level of the patient.

Ethical Considerations and Data Management

This study protocol was reviewed and approved by the Ege University Medical Research Ethics Committee (Approval Number: 24-6T/49, Date: 06.06.2024). Institutional permission to conduct the study was obtained from the Balıkesir Provincial Health Directorate. The trial was prospectively registered with ClinicalTrials.gov. All procedures are in compliance with the ethical principles outlined in the Declaration of Helsinki. Written informed consent is obtained from all participating caregivers prior to any study-related procedures. For patients who lack the capacity to provide consent, consent is obtained from their legally authorized representative. All collected data are anonymized using a unique study identification code. A master linking log is stored separately from the research data in a password-protected, encrypted file accessible only to the principal investigator. Data will be retained for a period of 10 years following study completion, in accordance with institutional and national regulations.

Data and Safety Monitoring

Given that this is a minimal-risk, educational intervention study with no investigational drug or device, a formal Data and Safety Monitoring Board (DSMB) was not required by the reviewing ethics committee. The principal investigator is responsible for the ongoing monitoring of the study's conduct, including the timely identification and documentation of any adverse events or unanticipated problems. The development of a new pressure injury in a patient, while an outcome of interest, is also monitored and recorded. Any serious adverse events that are determined to be related to study participation will be promptly reported to the Ege University Medical Research Ethics Committee.

Inclusion Criteria:

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

Exclusion Criteria:

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

Individual participant data will not be shared publicly due to ethical restrictions and the conditions outlined in the informed consent form approved by the Ege University Medical Research Ethics Committee. Data are only accessible to the named investigators for the purposes of this study.

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).