跳至主要内容
临床试验/NCT07744178
NCT07744178已完成不适用

Nurse-led Intervention for Cognitive Reserve and Stress Management for Teachers Approaching Retirement: a Cluster-randomized Controlled Trial

Cairo University1 个研究点 分布在 1 个国家目标入组 111 人开始时间: 2025年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
111
试验地点
1
主要终点
Change in Cognitive Reserve Assessment Scale in Health (CRASH)

研究概览

简要总结

As people approach retirement, leaving the workplace can reduce the mental, social, and physical stimulation that a demanding job provides, while also introducing new stress related to the transition. Both changes may affect long-term brain health and well-being, yet there is little evidence on programs that address them together before retirement particularly programs delivered by nurses in the workplace.

This study tested whether a brief, nurse-led group program could improve cognitive reserve (the mental resources that help a person maintain thinking ability despite age-related brain changes) and reduce perceived stress among primary school teachers aged 55 to 69 who were still working and approaching retirement. The four-week program combined cognitive-stimulation activities, stress-management and relaxation training, gentle psychomotor (movement and coordination) exercises, and guided planning for staying mentally, physically, and socially active after retirement. Teachers in the comparison group continued their usual activities and received an educational booklet after the program ended.

The trial used a cluster-randomized controlled design conducted in four public primary schools in Kafr El-Dawwar, Beheira Governorate, Egypt. Whole schools rather than individual teachers were randomly assigned, so that two schools received the program and two served as controls. Cognitive reserve and perceived stress were measured at baseline, immediately after the program, and again at 4 weeks, 3 months, and 6 months of follow-up.

详细描述

This interventional trial evaluated a nurse-led, workplace-based approach to supporting cognitive and psychological health during the pre-retirement period - a life stage in which changes to daily structure, occupational complexity, social contact, and role identity may influence later cognitive trajectories and stress. The rationale drew on cognitive-reserve theory together with evidence that persistent perceived stress can constrain the behavioral expression of reserve; the two prespecified outcomes were therefore evaluated concurrently rather than as independent targets. Development followed Medical Research Council guidance for complex interventions, and the intervention was specified using the Template for Intervention Description and Replication (TIDieR).

The school served as the unit of randomization, while the individual teacher was the unit of recruitment, delivery, and measurement. To limit selection bias, all eligible teachers within each participating school were invited and individual recruitment was completed before the allocation sequence was generated. A researcher responsible for the statistical analysis then generated the school-level sequence by computer, assigned schools 1:1 to conditions, and informed schools of their allocation afterward. Delivering the program at the level of the whole school was intended to reduce exchange of intervention materials between conditions (contamination). Because the program was educational and behavioral, participants and the nurse interventionists could not be masked; masking of outcome assessment and analysis was not undertaken, and both outcomes were self-reported.

The intervention was developed by the research team and reviewed by faculty experts in community-health, psychiatric mental-health, and gerontological nursing for content, cultural suitability, sequence, and feasibility. Standardized materials - an illustrated Arabic booklet, visual aids, activity materials, brief instructional videos, and session checklists supported consistent delivery. Two nurse-researchers rehearsed manualized session scripts and standardized timing, activity administration, attendance recording, and documentation of protocol deviations before implementation. Facilitators used content checklists to confirm delivery of planned objectives and to log any deviations in content or duration.

The primary analysis used complete-case linear mixed-effects models with fixed effects for group, time (as a categorical factor), and their interaction, plus a participant-level random intercept, estimated by restricted maximum likelihood. Because the archived analysis file did not contain the school identifier, these models accounted for repeated measures within participants but not for clustering of teachers within schools; with only four clusters, cluster-level variance and conventional asymptotic standard errors may be unstable. Inferential results are therefore interpreted as exploratory and are supported by two post hoc sensitivity analyses: a cluster-precision analysis applying a design-effect adjustment across a range of plausible intracluster correlation coefficients, and a series of progressively adverse missing-outcome scenarios. No a priori cluster-adjusted sample-size calculation was performed; census-style recruitment was used, and interpretation emphasizes effect estimates and their uncertainty rather than post hoc power.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
55 Years 至 69 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Employed teacher at one of the four participating public primary schools in Kafr El-Dawwar, Beheira Governorate, Egypt
  • Able to communicate in Arabic
  • Willing and able to provide written informed consent

排除标准

  • Declined to participate or did not provide written informed consent
  • Participation in pilot testing of the study instruments

研究组 & 干预措施

Control arm - Usual Activities with Delayed Booklet Participants continued their usual educational

No Intervention

Control arm:

Participants in the control schools continued their usual educational and occupational activities during the four-week program period and did not receive the structured cognitive-intervention sessions, psychomotor training, stress-intervention instruction, text-message reminders, or assigned home practice given to the intervention arm. The standardized educational booklet was provided to control schools only after the immediate post-program assessment, so later follow-up contrasts reflect the full program versus delayed booklet exposure rather than unchanged usual activity.

Intervention arm:

Experimental

Intervention arm:

Participants received a brief multicomponent program delivered by two nurse-researchers over four consecutive weeks, comprising 12 group sessions: 8 cognitive-intervention sessions (twice weekly) and 4 psychomotor and stress-intervention sessions (once weekly). Sessions lasted approximately 45-60 minutes in groups of no more than 8 teachers, following a standardized sequence of orientation, demonstration, guided practice, feedback, and brief home practice. Cognitive-intervention sessions targeted memory, language, attention, and executive function; psychomotor and stress-intervention sessions addressed posture, balance, coordination, and ergonomics alongside coping skills, relaxation, mindfulness-informed practice, and behavioral action planning. Post-retirement behavioral planning was integrated across all four weeks. Reinforcement included an Arabic illustrated booklet, visual aids, brief instructional videos, home practice, and SMS reminders.

干预措施: Nurse-Led Multicomponent Program (cognitive stimulation, psychomotor activity, and stress management) (Other)

结局指标

主要结局

Change in Cognitive Reserve Assessment Scale in Health (CRASH)

时间窗: Baseline, immediately after the 4-week program, 4 weeks after program completion, 3 months after program completion, and 6 months after program completion

The Cognitive Reserve Assessment Scale in Health (CRASH) is a 33-item self-report instrument covering education, occupational attainment, and intellectual and leisure activities. The global score is calculated using the validated weighted-domain formula \[(education × 6) + (occupation × 11.25) + leisure\] / 3. Total scores range from 0 to 90, with higher scores indicating greater cognitive reserve-related exposure. The total score is analyzed as a continuous variable; no data-derived categories or cut-off values are applied.

次要结局

  • Change in 10-item Perceived Stress Scale (PSS-10)(Baseline, immediately after the 4-week program, 4 weeks after program completion, 3 months after program completion, and 6 months after program completion)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Eman Mahmoud Seif EL-Nasr

Assistant Professor of Community Health Nursing, Faculty of Nursing, Cairo University

Cairo University

研究点 (1)

Loading locations...

相似试验