Comprehensive Geriatric Assessment in Primary Care

NCT ID: NCT07341061

Last Updated: 2026-01-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-12
• Study Completion Date: 2029-01-12

Brief Summary

This study evaluates the feasibility and acceptability of implementing the electronic Comprehensive Geriatric Assessment (eCGA) in primary care for adults aged 65 years and older. The study examines how frailty changes over 12 months, how patient self-assessments compare with physician assessments, and how patients perceive the value of the eCGA when used as part of routine care.

The study also includes an interventional randomized sub-study (PAHA), in which eligible participants receive a personalized physical activity program developed by a Clinical Exercise Physiologist. Participants are randomized to either an immediate-start or delayed-start exercise group, allowing assessment of the effects of a tailored activity intervention on frailty, physical activity participation, and goal attainment.

Findings will inform how eCGA tools and personalized activity interventions can be integrated into primary care to support healthy aging and frailty management.

Detailed Description

This study investigates the use of the electronic Comprehensive Geriatric Assessment (eCGA) in primary care as a structured approach to identifying frailty, monitoring change over time, and informing individualized care planning for older adults. The eCGA is an electronic adaptation of the Comprehensive Geriatric Assessment used in geriatric care, integrated into the TELUS electronic medical record used in Nova Scotia. Embedding the eCGA directly within the EMR is designed to improve feasibility and uptake by allowing primary care physicians to efficiently review key domains of mobility, cognition, mood, comorbidities, medications, and daily function during routine care encounters to generate a frailty index (FI).

The main study is a prospective, longitudinal cohort conducted in a primary care clinic. Up to 120 adults aged 65 and older will complete baseline eCGA assessments, patient-reported frailty and health questionnaires with follow-up at 12-months. We will investigate changes in frailty status, concordance between physician and patient frailty assessments (eCGA Frailty Index, Clinical Frailty Scale, Pictorial Fit-to-Frail Scale, Health Questionnaire - Frailty Index), patient experiences with the eCGA process, and health service utilization. Quantitative analyses include descriptive statistics, paired comparisons, one-way ANOVA models, correlation analyses, and regression models to identify predictors of frailty change. Qualitative semi-structured interviews will explore participants' perspectives on the acceptability and perceived clinical value of the eCGA.

The study also includes a randomized interventional sub-study-the Personalized Approach for Healthy Aging (PAHA). Sixty to 120 participants will be randomized into two groups.

Group AB (Immediate Exercise Group) will receive a tailored physical activity intervention beginning at baseline.

Group BA (Delayed Exercise Group) will receive the same intervention beginning after an initial waiting period.

The intervention is delivered by a Clinical Exercise Physiologist and includes individualized goal setting using Goal Attainment Scaling, a tailored exercise prescription, and structured follow-up contacts (weekly in month 1, biweekly in month 2, then monthly to month 6. This will vary by participant as needed). Randomization is stratified by Clinical Frailty Scale score.

The PAHA sub-study evaluates whether a personalized exercise intervention can improve physical activity levels (Physical Activity Scale for the Elderly), frailty progression, and individualized goals. Mixed-effects models will be used to examine longitudinal changes in activity and frailty, with "time zero" defined as the start of the intervention for each participant. Time points prior to and after the start of the intervention will be analyzed to evaluate treatment effects, carry-over effects, and sequence effects. Participants who withdraw early will still contribute available data, consistent with mixed-model analytic methods.

Safety monitoring is integrated into both clinical practice and the study design. All participants undergo a physician assessment prior to sub-study enrollment; referrals to physiotherapy or occupational therapy occur when clinically appropriate. The Clinical Exercise Physiologist monitors symptoms, adherence, and adverse events at each contact and modifies exercise prescriptions as necessary. All serious adverse events potentially related to the intervention are reviewed by the Principal Investigator and reported in accordance with institutional policy.

Qualitative and quantitative data will be triangulated to provide a comprehensive understanding of the feasibility, acceptability, and potential clinical impact of integrating frailty assessment and tailored physical activity support into routine primary care for older adults.

Conditions

Frailty; Aging; Geriatric Syndromes; Mobility Limitation; Functional Decline; Sedentary Lifestyle

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Group AB - immediate exercise group

Participants begin the Personalized Approach for Healthy Aging (PAHA) physical activity intervention immediately after basline assessment. The intervention includes individualized goal setting using Goal Attainment Scaling, tailored exercise prescription, and structured follow-up contacts with a Clinical Exercise Physiologist.

Group Type: EXPERIMENTAL

Personalized Approach for Healthy Aging (PAHA)

Intervention Type: BEHAVIORAL

A personalized physical activity and behaviour-change program delivered by a Clinical Exercise Physiologist, including individualized goal setting, tailored home-based exercise prescriptions, and structured follow-up contacts (telephone or virtual) over 6 months.

Group BA - 6-month delayed exercise group

Participants begin the PAHA physical activity intervention after a delayed-start period. They complete the same assessments and receive the same individualized exercise program as Group AB (immediately exercise group) but begin the intervention later in the study.

Group Type: ACTIVE_COMPARATOR

Personalized Approach for Healthy Aging (PAHA)

Intervention Type: BEHAVIORAL

A personalized physical activity and behaviour-change program delivered by a Clinical Exercise Physiologist, including individualized goal setting, tailored home-based exercise prescriptions, and structured follow-up contacts (telephone or virtual) over 6 months.

Interventions

Personalized Approach for Healthy Aging (PAHA)

A personalized physical activity and behaviour-change program delivered by a Clinical Exercise Physiologist, including individualized goal setting, tailored home-based exercise prescriptions, and structured follow-up contacts (telephone or virtual) over 6 months.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Older adult patients receiving care at the Dalhousie Family Medicine Clinic and scheduled to undergo an eCGA as part of routine primary care.
• Fluent in English and able to respond to interview and questionnaire items.
• Able to provide informed consent; or, if judged unable to consent, able to provide assent AND has a substitute decision maker (SDM) who is willing to provide informed consent on their behalf.
• (PAHA sub-study) Enrolled in the main eCGA study, willing to participate in a personalized physical activity- program, and available for follow-up contact.

Exclusion Criteria

• Not scheduled for, or not receiving, an eCGA at the investigator's family medicine clinic.
• Unable to communicate in English, such that questionnaires and interviews cannot be completed.
• Unable to provide informed consent and no SDM available or willing to consent on the patient's behalf.
• (PAHA sub-study) Deemed unsuitable for the physical activity intervention by the treating family physician (e.g., medical or functional condition that, in the physician's judgment, makes participation in light-moderate exercise unsafe).

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nova Scotia Health Authority

OTHER

Sponsor Role: lead

Responsible Party

Barry Clarke

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Barry Clarke, MD

Role: PRINCIPAL_INVESTIGATOR

Nova Scotia Health

Central Contacts

Jodie Penwarden, MFSGN

Role: CONTACT

Jodie.Penwarden@nshealth.ca

902-473-7705

Other Identifiers

2021-1962

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

1032253

Identifier Type: -

Identifier Source: org_study_id