Designing, validation and evaluation of an mHealth app for prenatal health promotion based on the unified theory of acceptance and use of technology: A mixed methods study protocol

Design of the combined strategies research

This research employs an exploratory sequential mixed-methods design, guided by the taxonomy growth mannequin. The analysis begins with a qualitative section, adopted by a quantitative section, permitting for the combination of in-depth contextual understanding with generalizable testing. This design permits a scientific exploration of customers’ views to tell the event, validation, and analysis of a culturally tailor-made mHealth utility for prenatal well being promotion. The research protocol has undergone peer evaluate as a part of the funding course of and obtained moral approval from the Analysis Ethics Committee of Mashhad College of Medical Sciences, Iran.

To make sure methodological rigor, the qualitative section adheres to the 10-step information by Kaba et al.²⁸and the quantitative section (a randomized managed trial) follows the SPIRIT (Normal Protocol Objects: Suggestions for Interventional Trials) guidelines²⁹.

In Section I (Qualitative research), a directed content material evaluation utilizing the Unified Idea of Acceptance and Use of Know-how (UTAUT) shall be carried out to grasp pregnant ladies’s perceptions and experiences relating to health-promoting behaviors and mHealth app use. The findings from this section—mixed with a evaluate of prenatal care tips, related literature, and present apps—will inform the app’s design and guarantee theoretical alignment.

In Section II (App Design and Validation), the app shall be developed utilizing the ADDIE educational design mannequin. Suggestions from each pregnant ladies and discipline specialists shall be built-in iteratively to validate the app’s content material, usability, and performance.

In Section III (Quantitative Analysis), the app shall be evaluated through a randomized managed trial to find out its effectiveness in bettering health-promoting behaviors, in addition to consumer acceptance and continued engagement with the mHealth intervention.

Integration of qualitative and quantitative information will happen at a number of phases—design, implementation, and interpretation—to make sure that consumer wants and cultural context are embedded all through the research. A joint show shall be used to attach qualitative themes with quantitative outcomes primarily based on the UTAUT mannequin (Fig. 2).

Section I. Qualitative analysis research design

Within the qualitative section, a directed content material evaluation primarily based on the UTAUT shall be employed to look at pregnant ladies’s perceptions and experiences relating to health-promoting behaviors and the usage of mHealth purposes. Directed content material evaluation is a qualitative analysis methodology employed to validate or prolong an present theoretical framework or principle. This methodology is especially efficient in research aiming to check pre-established theories or mannequin³⁰ In Iran, mHealth know-how, particularly within the realm of being pregnant care, is comparatively new, presenting a singular cultural and social setting for investigating pregnant ladies’s acceptance and utilization behaviors. The adoption of know-how in Iran is influenced by particular societal values and practices, necessitating an intensive understanding of those elements for efficient and sustainable mHealth implementation. The novelty of mHealth in Iran presents a possibility to judge the UTAUT mannequin inside this rising context, offering insights into its cross-cultural applicability. Using directed content material evaluation with the UTAUT framework permits a structured but adaptable exploration, making certain that the evaluation stays theory-driven whereas incorporating new cultural views. This strategy enhances the credibility and transferability of the research, providing a complete understanding of the analysis downside. Insights from this section will inform the design and validation of a smartphone utility tailor-made to the particular wants of pregnant ladies.

Qualitative analysis setting

On this research, the analysis setting will embody well being facilities, midwifery clinics affiliated with Mashhad College of Medical Sciences, midwifery counseling clinics, and the personal clinics of midwives and gynecologists. These places shall be used for figuring out contributors within the first section of the research.

Pattern dimension and its justification

Within the qualitative section, pattern dimension is decided by the precept of information saturation, the place interviews proceed till no new data emerges. Based mostly on proof from a scientific evaluate of empirical research on information saturation in qualitative analysis, thematic saturation is often achieved inside 12 to twenty interviews³¹. Accordingly, we anticipate conducting roughly 15 to twenty interviews with pregnant ladies to make sure sufficient depth and breadth of thematic exploration on this research. This vary is taken into account enough to realize saturation in theory-driven qualitative analysis utilizing the UTAUT framework. Saturation shall be decided when no new codes, themes, or views emerge from a minimum of two consecutive interviews. The analysis workforce will usually evaluate transcripts and coding patterns throughout information assortment to watch saturation.

As well as, 12 stakeholders from varied disciplines shall be interviewed to assemble numerous skilled insights that inform app design, cultural tailoring, and implementation feasibility. This multidisciplinary enter is anticipated to reinforce the content material validity and contextual relevance of the mHealth intervention.

Inclusion and exclusion standards

Inclusion standards for pregnant ladies will embody:

• Age between 18 and 45 years.

• Singleton being pregnant.

• Gestational age between 12 and 28 weeks (to make sure sufficient time for participation).

• Possession of a smartphone and primary proficiency in utilizing cell purposes.

• Minimal schooling stage of highschool diploma or equal.

• Capability and willingness to offer knowledgeable consent and take part in an interview carried out in Persian.

Exclusion standards for pregnant ladies will embody:

• Prognosis of a high-risk being pregnant requiring specialised medical consideration.

• Identified cognitive or psychological issues which will impair participation.

• Incapability to offer knowledgeable consent.

Inclusion standards for skilled stakeholders will embody:

• Midwives or obstetricians with a minimum of six months of expertise in maternal care inside medical or group settings (e.g., hospitals, clinics, or well being facilities).

• Medical informatics specialists with expertise within the design, growth, or implementation of mHealth applied sciences.

• Social science researchers with qualitative analysis expertise in digital well being, well being literacy, or maternal well being conduct.

Sampling methodology

Members shall be chosen by means of purposive sampling with most variation to make sure a broad and numerous illustration of experiences. This strategy will keep in mind elements reminiscent of age, socio-economic standing, instructional background, occupation, and being pregnant historical past to seize a wide selection of viewpoints. After receiving approval from Mashhad College of Medical Sciences, contributors shall be invited to affix the research primarily based on their direct expertise with cell well being purposes throughout being pregnant.

Information assortment will proceed till thematic saturation is achieved, which means that no new data or themes will emerge from extra interviews. This may be certain that the research totally explores the analysis questions whereas adhering to the rules of qualitative analysis.

Qualitative information assortment

Information shall be collected by means of semi-structured, in-depth interviews to permit contributors to freely specific their experiences and views. An preliminary interview information shall be developed primarily based on the constructs of the UTAUT framework, together with efficiency expectancy, effort expectancy, social affect, and facilitating situations.

Within the context of this research, every UTAUT assemble shall be operationalized as follows:

• Efficiency Expectancy: Perception that the app will enhance maternal well being. Addressed by means of personalised schooling, well being monitoring, and motivational suggestions; assessed through interviews and a validated UTAUT-based questionnaire.

• Effort Expectancy: Perceived ease of use. App options embody intuitive navigation, visible icons, voice steering, and offline entry. Evaluated by means of consumer suggestions on interface and accessibility.

• Social Affect: Perceived assist from vital others. Operationalized by means of options like family-sharing, joint decision-making prompts, and partner-involved content material.

• Facilitating Circumstances: Perceived availability of assist and infrastructure. Addressed through in-app steering, technical assist, and concerns of customers’ digital entry and literacy.

These constructs will information each the qualitative exploration (Section 1) and the app analysis (Section 3) to make sure the intervention is grounded in related adoption determinants.

The information will embody open-ended questions and prompts aligned with the UTAUT framework. It is going to be reviewed by specialists in reproductive well being, medical informatics, and qualitative analysis to make sure readability and content material validity. A pilot take a look at with 2–3 pregnant ladies shall be carried out to evaluate stream and comprehensibility, with ultimate changes made earlier than formal information assortment.

Interviews shall be audio-recorded, transcribed verbatim, and carried out in participant-convenient settings. Periods will final roughly 30–90 min, and non-verbal cues shall be documented. All interviews shall be carried out by the primary creator, a educated midwife and qualitative researcher. Demographic information may even be collected to contextualize findings.

Recruitment will proceed till information saturation, with an estimated pattern dimension of ~ 20 contributors, primarily based on comparable qualitative research. This strategy goals to yield a wealthy understanding of girls’s wants, expectations, and behaviors associated to mHealth throughout being pregnant.

Qualitative information evaluation

The information evaluation course of was grounded within the deductive strategy of directed qualitative content material evaluation as outlined by Elo and Kyngäs (2008)³²encompassing three phases of preparation, group, and reporting.

Within the preparation section, the unit of study shall be complete interview transcripts. Researchers will immerse themselves within the information by studying transcripts repeatedly to achieve contextual understanding and can doc reflective notes on speaker roles, situational context, and potential influences.

Within the group section, a structured categorization matrix shall be developed primarily based on the 4 core UTAUT constructs: efficiency expectancy, effort expectancy, social affect, and facilitating situations. Every assemble shall be outlined operationally, knowledgeable by the UTAUT framework and related literature. For instance, efficiency expectancy will confer with the perceived usefulness of the mHealth app in supporting maternal well being.

A deductive coding strategy shall be used to assign which means models to predefined classes. When information don’t match the preliminary framework, inductive open coding shall be utilized to generate emergent subcategories. These shall be reviewed by the analysis workforce for relevance and potential growth of the theoretical framework³³.

To make sure coding reliability, two impartial researchers will initially code a pattern of transcripts. Cohen’s Kappa shall be used to evaluate inter-coder settlement, with discrepancies resolved by means of dialogue with a senior qualitative professional. A coding handbook shall be developed and iteratively refined. Audit trails, memo-writing, and peer debriefings will assist analytic transparency. Member checks with chosen contributors shall be carried out to verify interpretive accuracy.

Within the reporting section, findings shall be introduced below every UTAUT assemble, together with each confirming and disconfirming information. Relationships amongst classes shall be mentioned to discover how pregnant ladies understand and interact with mHealth instruments (32). The mixed use of a theory-driven matrix and inductive openness enhances each theoretical rigor and contextual relevance.

Trustworthiness

The reliability of the analysis shall be ensured by adhering to the Lincoln and Guba’s (1985) 4 requirements for rigor in qualitative research, which incorporates credibility, dependability, confirmability and transferability³⁴. To reinforce the credibility of the research, the researcher will fully immerse within the information and return the coded texts to the contributors for his or her affirmation of the researcher’s understanding. Moreover, the interviews and coding shall be reviewed by supervising professor and professional reviewers to additional bolster information credibility. Additionally, the researcher’s educational coursework, a number of years of expertise as a midwife, and sensible expertise in offering care to pregnant ladies will contribute to elevated theoretical sensitivity and analysis credibility.

Dependability refers back to the stability and reliability of the findings over time and below completely different situations³⁵. On this research, an exterior auditor shall be requested to look at discrepancies and similarities of findings with the researcher’s interpretation. Efforts shall be made to keep away from extended information assortment interval as a lot as potential, and all contributors shall be requested a few particular matter to make sure consistency.

Confirmability signifies the extent to which the information are linked to the sources and the interpretations drawn³⁵. To attain this criterion, a complete description of the analysis processes, together with information assortment, evaluation, and theme growth, shall be supplied to permit for auditability by readers. Moreover, the textual content of some interviews, together with extracted codes and classes, shall be made accessible in order that exterior reviewers and non-participating people can assess the confirmability of the information.

Transferability displays the extent to which the findings derived from the information might be utilized to different settings or teams³². On this research, the researcher will present an in depth description of the demographic traits and experiences of the contributors and the analysis setting. The outcomes may even be reported to people not concerned within the research to permit them to evaluate the similarity between the analysis findings and their very own experiences.