Effectiveness and Cost-Effectiveness of In-Person, Online, and Hybrid Healthy-Aging Education for Community-Dwelling Older Adults With Pre-Frailty or Frailty: A Four-Arm Randomized Controlled Trial (FRAGSALUD-ON)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 276
- 试验地点
- 1
- 主要终点
- Change From Baseline in the Prespecified 40-Item Frailty Index Score at 6 Months
研究概览
简要总结
The goal of this clinical trial is to determine whether a 6-month healthy-aging education program delivered in person, online, or in a hybrid format reduces frailty and is cost-effective compared with usual care in community-dwelling adults aged 65 years or older with pre-frailty or frailty.
The main questions are:
- Do the three educational programs, considered together, reduce the prespecified 40-item Frailty Index (40-FI) at 6 months more than usual care?
- Are effects maintained 6 months after the programs end?
- How do the in-person, online, and hybrid educational programs differ in multidomain frailty outcomes, implementation, costs, and quality-adjusted life-years?
- Are changes in prespecified blood biomarkers and gut microbiota associated with changes in frailty and related outcomes?
The study will enroll 276 participants. Randomization will occur at household level so that enrolled cohabitants receive the same assignment. Households will be allocated to in-person education, online education, hybrid education, or usual care. All three educational programs address physical activity, nutrition, cognitive and emotional well-being, and social connection. Assessments will occur at baseline, 6 months, and 12 months; blood and stool samples will be collected at baseline and 6 months. The trial will compare the average effect of the three active programs with usual care and will estimate modality-specific clinical and economic outcomes.
详细描述
Frailty is a potentially modifiable state of reduced physiological reserve that increases vulnerability to falls, disability, hospitalization, loss of independence, and higher healthcare use. Multidomain programs addressing physical activity, nutrition, cognitive and emotional health, and social participation can improve frailty-related outcomes. However, it remains uncertain how in-person, online, and hybrid delivery differ in effectiveness, reach, implementation, resource use, and cost-effectiveness. The trial is not designed to establish equivalence or non-inferiority among the three active modalities. FRAGSALUD-ON builds on the previous FRAGSALUD program by comparing three delivery modalities within the same randomized trial and by integrating clinical, behavioral, biological, implementation, and economic evaluations.
This is a 12-month, four-arm, parallel-group, household-cluster randomized controlled trial conducted in the province of Cadiz, Spain. The household is the unit of randomization: a participant without another enrolled cohabitant constitutes a cluster of one, and all enrolled cohabitants are assigned to the same study arm. Households, rather than individual participants, will be allocated in a 1:1:1:1 ratio to in-person education, online education, hybrid education, or usual care. The target enrollment is 276 participants; participant numbers per arm are expected to be approximately, but not necessarily exactly, equal. Randomization will be performed by an independent statistician who is not involved in recruitment or outcome assessment. Participants and intervention providers cannot be masked because of the nature of the programs. Outcome assessors will remain unaware of group allocation whenever feasible. Assessments will be conducted at baseline, at the end of the 6-month intervention, and 6 months after the intervention ends (12 months after baseline). Blood and stool samples will be obtained at baseline and 6 months.
The three active interventions share four core domains: physical activity, nutrition, cognitive and emotional well-being, and social connection. The in-person group will attend four weekly group sessions during the first month and receive six reinforcement telephone calls during the following 5 months. The hybrid group will attend the same four group sessions plus a digital-platform onboarding session and will use the online platform for reinforcement during the following 5 months instead of receiving the telephone calls. The online group will receive an onboarding session and will use the platform as the main educational delivery method throughout the 6-month intervention.
Educational materials were developed before participant recruitment with artificial-intelligence assistance and were subsequently reviewed, edited, and approved by the research team. Artificial intelligence was used solely to support the development of educational materials before participant recruitment. It will not receive participant data, interact with participants, personalize intervention content, monitor adherence, or provide clinical advice during the trial. The platform will provide interactive educational modules, knowledge activities, navigation support, and automated reminders without artificial-intelligence processing of participant data.
The usual-care group will continue its routine healthcare and health routines and will not receive the FRAGSALUD-ON educational program during the 12-month follow-up. After completing the 12-month assessment, participants in this group will be offered access to the online educational platform, in accordance with the ethics-approved protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Participants and intervention providers cannot be masked because of the nature of the educational interventions. A designated investigator with no role in sequence generation, allocation release, recruitment, baseline assessment, intervention delivery, adherence monitoring, or access to unblinded operational data will remain unaware of group allocation and will oversee blinded outcome adjudication and prespecified analytic decisions. Primary and secondary outcome assessments will be performed by trained assessors who are independent of intervention delivery and unaware of group allocation. Participants will be reminded not to disclose their assigned group during assessment visits. Any accidental unmasking of an outcome assessor will be documented. Laboratory personnel and statisticians will work with coded group labels until the analysis dataset, derivation rules, and primary model have been finalized.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Community-dwelling adults aged 65 years or older.
- •Presence of pre-frailty or frailty according to the prespecified operationalization of the Fried frailty phenotype, defined as meeting at least one of the five Fried criteria (pre-frailty: 1-2 criteria; frailty: 3-5 criteria).
- •Ability to understand spoken and written Spanish sufficiently to follow the intervention and study procedures.
- •Access at home to Wi-Fi or mobile data and to a smartphone, tablet, or computer capable of connecting to the internet.
- •Ability to attend the study assessments and, if randomized to the in-person or hybrid intervention, the scheduled face-to-face sessions.
- •Ability to understand the study information and provide written informed consent.
排除标准
- •Permanent residence in a nursing home or other long-term residential care institution.
- •Robust status according to the Fried frailty phenotype, defined as meeting none of the five Fried criteria.
- •Severe dementia or any cognitive, neurological, or psychiatric condition that precludes valid informed consent or the ability to understand and follow the study procedures.
- •Use of systemic antibiotics during the 3 months preceding baseline stool-sample collection.
- •Known terminal illness or receipt of end-of-life care, with an anticipated life expectancy of less than 12 months, based on available clinical documentation or assessment by a qualified clinician.
- •Current participation in another interventional study involving an investigational medicinal product or a structured physical activity, nutritional, cognitive, or social intervention that overlaps with the FRAGSALUD-ON intervention or follow-up period.
结局指标
主要结局
Change From Baseline in the Prespecified 40-Item Frailty Index Score at 6 Months
时间窗: Baseline and 6 months
A prespecified 40-item deficit-accumulation Frailty Index (40-FI) will be calculated as the sum of observed deficit scores divided by the number of evaluable deficits. The 40-FI ranges from 0 to 1, with higher values indicating greater frailty. A score will be calculated when at least 32 of the 40 deficits (80%) are evaluable. Change will be calculated as the 6-month score minus the baseline score; negative values indicate improvement. The fixed item list, item-level coding rules, permitted intermediate values, denominator, and missing-data rules are defined in the version-controlled 40-FI Specification included as an annex to Protocol and SAP and finalized before enrolment of the first participant.
次要结局
- Change From Baseline in the Prespecified 40-Item Frailty Index Score at 12 Months(Baseline and 12 months)
- Change From Baseline in the Fried Frailty Phenotype Score at 6 and 12 Months(Baseline, 6 months, and 12 months)
- Change From Baseline in Maximum Dominant-Hand Grip Strength at 6 and 12 Months(Baseline, 6 months, and 12 months)
- Change From Baseline in Short Physical Performance Battery Total Score at 6 and 12 Months(Baseline, 6 months, and 12 months)
- Change From Baseline in Best Eyes-Open 30-Second Single-Leg Stance Time at 6 and 12 Months(Baseline, 6 months, and 12 months)
- Change From Baseline in Fast-Pace 4-Meter Gait Speed at 6 and 12 Months(Baseline, 6 months, and 12 months)
- Change From Baseline in Estimated Relative Sit-to-Stand Mean Power at 6 and 12 Months(Baseline, 6 months, and 12 months)
- Change From Baseline in Barthel Index Total Score at 6 and 12 Months(Baseline, 6 months, and 12 months)
- Change From Baseline in Lawton Instrumental Activities of Daily Living Total Score at 6 and 12 Months(Baseline, 6 months, and 12 months)
- Change From Baseline in Accelerometer-Measured Moderate-to-Vigorous Physical Activity at 6 and 12 Months(Baseline, 6 months, and 12 months)
- Change From Baseline in Full Mini Nutritional Assessment Total Score at 6 and 12 Months(Baseline, 6 months, and 12 months)
- Change From Baseline in Montreal Cognitive Assessment Total Score at 6 and 12 Months(Baseline, 6 months, and 12 months)
- Change From Baseline in Pittsburgh Sleep Quality Index Global Score at 6 and 12 Months(Baseline, 6 months, and 12 months)
- Change From Baseline in Depressive Symptoms Assessed With the 15-Item Geriatric Depression Scale at 6 and 12 Months(Baseline, 6 months, and 12 months)
- Change From Baseline in EQ-5D-5L Index Value at 6 and 12 Months(Baseline, 6 months, and 12 months)
- Change From Baseline in EQ Visual Analogue Scale Score at 6 and 12 Months(Baseline, 6 months, and 12 months)
- Rate of Falls During the 12-Month Follow-up(From randomization through 12 months)
- Change From Baseline in Perceived Functional Social Support Assessed With the Duke-UNC-11 at 6 and 12 Months(Baseline, 6 months, and 12 months)
- Change From Baseline in Serum High-Sensitivity C-Reactive Protein Concentration at 6 Months(Baseline and 6 months)
- Total Societal Cost per Participant Over 12 Months(From baseline through 12 months)
- Quality-Adjusted Life-Years Accrued Over 12 Months(From baseline through 12 months)
- Change From Baseline in Gut Microbiota Shannon Diversity Index at 6 Months(Baseline and 6 months)
- Change in Overall Gut Microbiota Community Composition at 6 Months(Baseline and 6 months)