- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07744178
Nurse-led Intervention for Cognitive Reserve and Stress Management
Nurse-led Intervention for Cognitive Reserve and Stress Management for Teachers Approaching Retirement: a Cluster-randomized Controlled Trial
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.
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Cairo, Egypt
- Cairo University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria
- 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
Exclusion Criteria:
- Declined to participate or did not provide written informed consent
- Participation in pilot testing of the study instruments
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Intervention arm:
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. |
Nurse-Led Multicomponent Program (Behavioral) A brief multicomponent program delivered by two nurse-researchers over four consecutive weeks, comprising 12 group sessions: 8 cognitive-stimulation sessions (twice weekly) and 4 psychomotor and stress-interventiosessions (once weekly). Sessions lasted approximately 45-60 minutes in groups of no more than 8 teachers and followed a standardized sequence of orientation, facilitator demonstration, guided practice, feedback, and brief home practice. Cognitive-interventio sessions targeted memory, language, attention, and executive function through structured tasks (storytelling, verbal-fluency exercises, memory and board games, problem-solving, and writing/drawing activities). Psychomotor and stress-interventi 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 week |
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No Intervention: Control arm - Usual Activities with Delayed Booklet Participants continued their usual educational
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Cognitive Reserve Assessment Scale in Health (CRASH)
Time Frame: Baseline, immediately after the 4-week program, 4 weeks after program completion, 3 months after program completion, and 6 months after program completion
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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.
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Baseline, immediately after the 4-week program, 4 weeks after program completion, 3 months after program completion, and 6 months after program completion
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in 10-item Perceived Stress Scale (PSS-10)
Time Frame: Baseline, immediately after the 4-week program, 4 weeks after program completion, 3 months after program completion, and 6 months after program completion
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The 10-item Perceived Stress Scale (PSS-10) measures the extent to which respondents appraise their lives during the previous month as unpredictable, uncontrollable, and overloaded.
Each item is rated from 0 (never) to 4 (very often).
Items 4, 5, 7, and 8 are reverse-scored before summation.
Total scores range from 0 to 40, with higher scores indicating greater perceived stress.
The total score is analyzed as a continuous variable; no diagnostic cut-off values are applied.
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Baseline, immediately after the 4-week program, 4 weeks after program completion, 3 months after program completion, and 6 months after program completion
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Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CairoU EMSiefEL-Nasr
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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