Evaluating the PM ACTIVAS Nurse-Led Preventive Care Model for Community-Dwelling Older Adults: A Randomized Controlled Trial

1. Introduction

Maintaining functional ability has become one of the principal goals of health systems caring for rapidly ageing populations. The World Health Organization (WHO) defines healthy ageing as the process of developing and maintaining the functional ability that enables well-being in older age, shifting the focus of care from disease treatment toward preserving intrinsic capacity, autonomy, and quality of life [1,2]. This paradigm recognizes that enabling older adults to remain safely in their own homes and communities ("ageing in place") requires proactive, person-centred, and community-based models of care that identify modifiable risks before disability occurs. Consequently, preventive care has become a strategic priority for primary health care [3], positioning nurses to lead comprehensive interventions that promote healthy ageing and maintain independence [1,4].

Falls represents one of the greatest threats to healthy ageing because they compromise not only physical health but also functional independence, confidence, and social participation. Approximately one in four community-dwelling older adults experiences at least one fall annually, making falls one of the leading causes of injury, disability, hospitalization, institutionalization, and mortality worldwide [4,5]. Beyond their physical consequences, falls frequently trigger fear of falling, reduced mobility, social isolation, and progressive loss of functional capacity, often initiating a cycle of dependency that substantially affects quality of life and healthcare utilization [6]. Current evidence recognizes that falls rarely result from a single cause; instead, they emerge from complex interactions among intrinsic factors, medications, behaviors, environmental hazards, and social circumstances that evolve over time [4]. Preventing falls, therefore, should be understood as part of a broader strategy to preserve functional ability and support healthy ageing.

The growing recognition of this complexity has transformed fall prevention strategies over the past decade. International clinical guidelines now recommend comprehensive, multidimensional assessment followed by individualized interventions that address each older person's specific risk profile [4,7]. Although exercise remains the intervention supported by the strongest evidence, systematic reviews and recent clinical recommendations indicate that combining complementary strategies—including home hazard assessment and modification, medication review, education, behavioral counselling, and individualized care planning—can provide greater benefits for selected older adults [5,6,8,9,10]. However, important debate remains regarding the relative contribution of each intervention component and the populations most likely to benefit from multifactorial approaches. Increasingly, researchers argue that successful prevention depends not only on the intervention components themselves but also on the extent to which care is individualized, acceptable to older adults, and responsive to their living context and preferences [11,12]. These observations suggest that the challenge is no longer simply identifying effective intervention components, but delivering them in a coordinated and sustainable manner within routine primary health care.

Although multifactorial interventions are increasingly recommended, evidence regarding comprehensive nurse-led preventive care models capable of operationalizing evidence-based fall prevention within routine primary health care remains limited, particularly in Latin America [13,14,15]. Most randomized trials have evaluated isolated intervention components, whereas fewer studies have examined integrated nurse-led models of preventive care that combine multidimensional assessment, individualized education, environmental modification, family involvement, and longitudinal follow-up within primary health care [13,16].

The PM ACTIVAS Program was developed in Chile as part of a broader research programme aimed at designing, implementing, and evaluating a comprehensive nurse-led preventive care model for community-dwelling older adults. The intervention protocol has been previously published [17], followed by a qualitative evaluation demonstrating its feasibility and acceptability among older adults and healthcare professionals [18]. The present study reports the final phase of this programme by evaluating the model's clinical effects through a randomized controlled trial.

Generating evidence on effective and implementable nurse-led preventive care models is essential to strengthen primary health care responses to population ageing. Accordingly, advancing fall prevention requires not only identifying effective intervention components but also developing care models capable of operationalizing this evidence within routine primary health care. Therefore, the aim of this study was to evaluate the clinical effectiveness of the PM ACTIVAS nurse-led preventive care model and to examine its potential to operationalize evidence-based fall prevention within routine primary health care.

2. Materials and Methods

2.1. Study Design

This paper reports the quantitative component of a broader mixed-methods research programme designed to develop, implement, and evaluate the PM ACTIVAS Model. Specifically, this study reports the findings of a two-arm randomized controlled trial conducted to evaluate the clinical effects of the intervention. The qualitative evaluation of feasibility, acceptability, and implementation experiences has been reported separately [18]. The overall programme followed the Medical Research Council framework for the development and evaluation of complex interventions [19].

The trial was conducted between January 2021 and April 2022 in primary health care centres in the municipality of Renca, Santiago, Chile. The study protocol was prospectively registered at ClinicalTrials.gov (https://clinicaltrials.gov/study/NCT04313062; 2022-05-02) and has been published previously, including the theoretical rationale, intervention development, implementation strategy, and complete intervention description according to the Template for Intervention Description and Replication (TIDieR) checklist [17]. Therefore, only a brief description of the intervention is presented here. The study is reported in accordance with the Consolidated Standards of Reporting Trials (CONSORT) guidelines. [20]

2.2. Study Setting and Participants

Participants were recruited from the "Más Adultos Mayores Autovalentes" Program implemented in primary health care centres. Community-dwelling older adults aged 65–80 years who were functionally independent and had completed the national preventive health assessment within the previous 12 months were considered eligible.

Individuals presenting severe visual or hearing impairment preventing effective communication, moderate or severe cognitive or mood disorders, hospitalization during recruitment, or residence outside the participating health centres' catchment area were excluded.

A total sample of 220 participants was estimated based on an 80% statistical power, a significance level of 0.05, an expected small-to-moderate effect size for fall frequency, and an anticipated attrition rate of 10%. The sample size calculation was based on the primary outcome (fall occurrence). Participants were randomly allocated in a 1:1 ratio to either the intervention group (n = 110) or the control group (n = 110). The participant recruitment and allocation process is presented in Figure 1.

2.3. PM ACTIVAS Intervention

Participants allocated to the intervention group received the PM ACTIVAS Model, a comprehensive nurse-led home-based preventive care model developed to reduce fall risk and preserve functional independence among community-dwelling older adults. The intervention was delivered by trained registered nurses over a 12-month period in addition to usual primary care.

Because the PM ACTIVAS intervention has been fully described elsewhere according to the TIDieR checklist, only the intervention components necessary to interpret the trial results are summarized below [17].

Briefly, the PM ACTIVAS nurse-led preventive care model operationalizes evidence-based fall prevention by integrating:

• o multidimensional assessment of intrinsic and extrinsic fall risk factors;
• o individualized risk management and shared care planning;
• o home environmental assessment and modification;
• o individualized education and counselling;
• o provision of a home safety kit;
• o family involvement whenever appropriate; and
• o structured monthly telephone follow-up to reinforce agreed preventive actions.

The intervention is grounded in person-centred care and seeks to operationalize individualized evidence-based fall prevention by translating multidimensional risk assessment into personalized behavioural and environmental strategies that support healthy ageing and ageing in place.

Participants allocated to the control group received usual primary care according to national guidelines, including a baseline home visit and routine health services available within the primary care system. Both groups completed a falls calendar throughout the follow-up period [17].

2.4. Outcome Measures

Primary Outcome

The primary outcome comprised two complementary measures: fall occurrence (≥1 fall during follow-up) and the total number of falls recorded during the 12-month follow-up period. Participants in both the intervention and control groups prospectively recorded falls using a monthly Falls and Events Calendar, which constituted the principal outcome measure of the randomized trial. The calendar was provided at recruitment, and parti-cipants were instructed to record the days on which a fall, trip, or related event occurred. Family members or caregivers living in the same household and involved in the study activities could also assist with the recording process. Both participants and caregivers were instructed to use a standardized definition of a fall as any event resulting in the person coming into contact with the ground, regardless of its severity or consequences.

To enhance the completeness and reliability of prospective reporting, participants were contacted by telephone once a month throughout the 12-month follow-up period. During these contacts, the research team emphasized the importance of keeping the Falls and Events Calendar complete and up to date and addressed any questions regarding its completion. When appropriate, contact could also be established with a family member who lived with the participant and was familiar with the study activities. The completed calendars were collected by the research team during the final home visit.

Falls occurring during the 12 months preceding enrollment were also retrospectively reported at baseline. However, these data were used for baseline characterization rather than to assess change in fall occurrence. Unlike the prospective follow-up, baseline reports were not based on systematic monitoring using the study calendar or a standardized definition of a fall and were subject to recall bias, particularly given the 12-month recall period in an older population. Therefore, baseline and follow-up fall counts were not considered directly comparable, and change in the number of falls from baseline to fo-llow-up was not used as an outcome. Instead, the primary outcome was based exclusively on prospectively recorded falls during the 12-month follow-up period.

Secondary Outcomes

Secondary outcomes included intrinsic and extrinsic fall risk factors, assessed using a 37-item checklist developed for the project; ability to identify environmental fall hazards, assessed using an illustrated home-hazard recognition tool comprising four household scenarios; and fear of falling. Earlier versions of the fall-risk and home-hazard recognition instruments have been used in a randomized controlled trial conducted by the same research team among older adults [10], while detailed descriptions of the instruments and their scoring procedures have been reported elsewhere [17].

2.5. Data Collection

Baseline assessments were conducted during home visits after confirming eligibility criteria and obtaining written informed consent. Data collection included a structured questionnaire composed of six modules, administration of study instruments, and blood pressure measurement. During the COVID-19 pandemic, recruitment and data collection followed institutional infection prevention measures, including personal protective equipment, daily symptom screening, and SARS-CoV-2 testing when required.

Follow-up assessments were completed 12 months after baseline. Falls were prospectively monitored using the monthly falls calendar throughout the study period.

2.6. Data Analysis

Quantitative Análisis

Baseline comparability between the intervention and control groups was assessed using Mann–Whitney U tests for continuous variables and chi-square tests for categorical variables. Although 205 participants completed the 12-month follow-up, information on fall occurrence was available for 145 participants because some self-reported fall follow-up forms were incomplete. Therefore, analyses of the primary outcome were conducted using complete-case data.

The primary outcome was analyzed using two complementary approaches. First, fall occurrence during the 12-month follow-up was dichotomized as having experienced at least one fall versus no falls and compared between the intervention and control groups using the chi-square test. Second, the total number of falls recorded during follow-up was analyzed as a count outcome using negative binomial regression, with intervention group as the main predictor. Sensitivity analyses were conducted to account for falls reported during the 12 months preceding enrollment. For the dichotomous outcome, binary logistic regression was used, with fall occurrence during follow-up as the dependent variable and intervention group and baseline fall occurrence as predictors. For the count outcome, negative binomial regression was used, with the number of falls during follow-up as the dependent variable and intervention group and the number of falls reported at baseline as predictors.

For secondary outcomes with reliable baseline measurements (fall-risk factors and home hazard recognition), analysis of covariance (ANCOVA) was performed, with the follow-up score as the dependent variable, intervention group as the fixed factor, and the corresponding baseline score as a covariate. Adjusted effect sizes (partial η²) were calculated to facilitate interpretation of the magnitude of between-group differences. This approach allowed between-group dif-ferences at follow-up to be estimated while adjusting for baseline outcome levels. For the dichotomous outcome (fear of falling), an analogous approach was applied using binary logistic regression, with fear of falling at follow-up as the dependent variable and in-tervention group and baseline fear of falling as predictors. Statistical significance was set at p < 0.05 for all analyses.

2.7. Ethical Considerations

The study was conducted in accordance with the Declaration of Helsinki and approved by the Institutional Ethics Committee of (Approval No. 190318014), approved on December 20th 2019. The trial was prospectively registered at ClinicalTrials.gov (https://clinicaltrials.gov/study/NCT04313062; 2022-05-02). Written informed consent was obtained from all participants before enrolment.

Generative artificial intelligence was not used during the design of the study, participant recruitment, data collection, statistical analysis, or interpretation of findings. Any AI-assisted support used during manuscript preparation was limited to editorial writing assistance and will be reported in the Acknowledgments section in accordance with the journal's policy.

3. Results

3.1. Participant Flow and Baseline Characteristics

A total of 220 community-dwelling older adults were randomized to either the PM ACTIVAS intervention group (n = 110) or the control group receiving usual primary care (n = 110). Of the 205 participants who completed the 12-month follow-up, complete data on the primary outcome (fall occurrence) were available for 145 participants because some self-reported monthly falls calendars contained incomplete information (Figure 1).

Baseline demographic and clinical characteristics were comparable between study groups (Table 1). No statistically significant differences were observed in age, sex, educational level, cognitive status, functional assessment, previous falls, fear of falling, baseline fall-risk factors, or home hazard recognition, indicating successful randomization.

3.2. Primary Outcome

During the 12-month follow-up, falls were reported by 17 participants (23.3%) in the intervention group and 19 participants (26.4%) in the control group. No statistically sig-nificant difference was observed between groups in fall occurrence (p = 0.666). Likewise, no significant between-group difference was found in the number of falls experienced during follow-up (p = 0.164) (Table 2).

Sensitivity analyses adjusting for falls reported during the 12 months preceding enrollment yielded similar findings. In the logistic regression model, baseline fall occurrence was significantly associated with fall occurrence during follow-up (OR = 2.62, 95% CI [1.19, 5.80]); however, no significant intervention effect was observed after adjustment for baseline fall occurrence (OR = 1.05, 95% CI [0.48, 2.30]). Similarly, in the negative binomial regression model, no significant difference in the rate of falls during follow-up was observed between the intervention and control groups after adjustment for the number of falls reported at baseline (IRR = 0.65, 95% CI [0.34, 1.26]). Baseline number of falls was also not significantly associated with the rate of falls during follow-up (IRR = 1.04, 95% CI [0.88, 1.38]). These findings indicate that adjustment for baseline falls did not materially alter the primary results.

3.3. Secondary Outcomes

Significant between-group differences were observed for two secondary outcomes (Table 2).

3.3.1. Changes in Fall-Related Risk Factors

Participants receiving the PM ACTIVAS intervention demonstrated significantly fewer modifiable fall-risk factors than those receiving usual care at the end of follow-up. After adjusting for baseline scores, the intervention group presented significantly fewer fall-related risk factors than the control group (p = 0.001). The magnitude of this difference was moderate (partial η² = 0.07) (Table 2).

3.3.2. Recognition of Environmental Fall Hazards

Participants receiving the PM ACTIVAS intervention also demonstrated a greater ability to recognize home hazards than those receiving usual care. After adjusting for baseline scores, participants in the intervention group demonstrated significantly greater recognition of environmental fall hazards than those receiving usual care (p = 0.044), with a small effect size (partial η² = 0.02) (Table 2).

3.3.3. Fear of Falling

No statistically significant differences between groups were observed regarding fear of falling after the intervention (Table 2).

4. Discussion

This study evaluated the clinical effects of the PM ACTIVAS nurse-led preventive care model among community-dwelling older adults within routine primary health care. Although the PM ACTIVAS nurse-led preventive care model did not significantly reduce fall occurrence or the number of falls over 12 months, it was associated with meaningful improvements in modifiable fall-risk factors and environmental hazard recognition. These findings suggest that the principal contribution of PM ACTIVAS lies not only in its evidence-based intervention components but also in the way evidence-based fall prevention was operationalized through a coordinated nurse-led preventive care model. This interpretation aligns with recent evidence indicating that the effectiveness of multifactorial interventions depends not only on the combination of intervention components but also on their individualized application, coordination, and integration into routine care [11,21].

The observed reduction in fall-risk factors is likely explained by the synergistic integration of multiple evidence-based strategies rather than by the effect of any single intervention component [22]. PM ACTIVAS combines multidimensional risk assessment, individualized education, home hazard identification, tailored recommendations, and longitudinal follow-up within the PM ACTIVAS nurse-led preventive care model. This approach is consistent with recent evidence indicating that the effectiveness of fall prevention programs depends on combining complementary intervention components that address both intrinsic and extrinsic risk factors while adapting preventive strategies to individual needs and contexts [23,24,25]. Furthermore, implementation research has demonstrated that successful community-based fall prevention requires more than evidence-based interventions alone; it also depends on effective coordination, patient engagement, adaptation to local settings, and sustained professional support throughout the implementation process [26,27]. Together, these findings suggest that the effectiveness of PM ACTIVAS may be attributable not only to its evidence-based intervention components but also to the structured nurse-led preventive care model through which those components were coordinated and integrated into routine primary health care. This may help explain why multifactorial interventions with similar components often demonstrate heterogeneous effectiveness across studies.

Our findings complement the current international evidence on community-based fall prevention by addressing an important gap between intervention efficacy and real-world implementation. Recent systematic reviews and clinical recommendations consistently conclude that multifactorial interventions can reduce fall risk among community-dwelling older adults, although their overall effects are often modest and heterogeneous across populations and intervention designs [7,11]. Rather than contradicting these findings, the PM ACTIVAS nurse-led preventive care model offers a practical implementation framework for operationalizing evidence-based fall prevention within routine primary health care. This implementation-oriented perspective aligns with recent calls to move beyond evaluating individual intervention components toward understanding how evidence-based strategies can be effectively delivered, coordinated, and sustained in real-world community settings [19,23,26]. Consequently, the contribution of the present study lies not only in the observed reductions in modifiable fall-risk factors but also in illustrating how evidence-based fall prevention can be systematically integrated into routine primary health care through coordinated nursing practice. Accordingly, the innovation of PM ACTIVAS resides less in the individual intervention components than in the structured nurse-led model through which those components are coordinated, individualized, and embedded within routine primary health care [28].

The implications of these findings extend beyond fall prevention itself. Falls are recognized as one of the leading causes of functional decline, loss of independence, and increased health care utilization among older adults, making their prevention a priority for primary health care systems facing rapid population aging [3]. In this context, PM ACTIVAS demonstrates how nurses can lead an integrated preventive care delivery model by integrating comprehensive assessment, individualized care planning, health education, home-based interventions, and longitudinal follow-up into routine practice [29,30,31]. This approach is consistent with recent clinical recommendations emphasizing that fall prevention should be embedded within comprehensive, person-centered care rather than delivered as isolated clinical activities [5,7,32]. By strengthening continuity of care and proactively addressing modifiable risk factors, nurse-led preventive models such as PM ACTIVAS may contribute not only to reducing fall risk but also to preserving functional capacity, promoting healthy aging, and improving the sustainability of primary health care services [2].

This study has several strengths that enhance the relevance of its findings. First, it evaluated a comprehensive nurse-led preventive care model implemented under routine primary health care conditions, enhancing the transferability of the findings to real-world primary health care practice. Second, the multidimensional assessment of intrinsic and extrinsic fall-risk factors enabled the evaluation of clinically meaningful changes beyond the occurrence of falls alone, capturing improvements in modifiable risk profiles that constitute important intermediate outcomes in fall prevention [27]. Nevertheless, several limitations should be acknowledged. The study was conducted within a single primary health care setting, which may limit the generalizability of the findings to other populations and health systems. Although participant retention was high throughout the study, incomplete self-reported monthly falls calendars resulted in missing primary outcome data for a subset of participants, reducing the sample available for the main effectiveness analysis. This may have limited statistical power to detect between-group differences in fall occurrence despite significant improvements in modifiable fall-risk factors. Furthermore, while the study evaluated fall occurrence, it did not examine other clinically important outcomes, including fall-related injuries, hospitalizations, or health-related quality of life. Future multicenter studies using standardized prospective outcome collection with longer follow-up periods are needed to determine whether the observed reductions in modifiable fall-risk factors translate into sustained reductions in falls and other clinically important outcomes across diverse primary health care settings, and to assess the model's transferability and scalability.

5. Conclusions

This study demonstrates that the PM ACTIVAS nurse-led preventive care model can reduce modifiable fall-risk factors among community-dwelling older adults when integrated into routine primary health care. These findings reinforce the growing role of nurses as leaders in implementing evidence-based preventive care strategies. By integrating evidence-based interventions into a coordinated nurse-led preventive care model, PM ACTIVAS offers a transferable framework for strengthening healthy ageing policies and preventive primary health care for community-dwelling older adults. The principal contribution of this study lies not only in demonstrating improvements in modifiable fall-risk factors, but also in showing how evidence-based fall prevention can be systematically integrated into routine primary health care through a structured nurse-led preventive care model.