Comprehensive Geriatric Assessment in Primary Care

NCT07341061 | Not Yet Recruiting

• 2 other identifiers: 10322532021-1962
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

Frailty; eCGA; electronic Comprehensive Geriatric Assessment; Primary Care; Frailty Index; Clinical Frailty Scale; Older Adults; Healthy Aging; Physical Activity Intervention; Exercise Intervention; Geriatric Assessment

Outcome Measures

Primary Outcomes (6)

• Comprehensive Geriatric Assessment - Frailty Index

  A comprehensive geriatric assessment (CGA) of the participants' global health state, including their current and relevant past illnesses, medications, cognition, emotion, motivation, health attitude, communication, sleep, pain, control of life, strength, balance, mobility, activities and instrumental activities of daily living, quality of life, lifestyle, and social engagement are assessed. Information to inform the CGA is derived from participant interviews, structured assessments and tests, and medical record review. Each CGA item will be recoded to a scale from 0 to 1, with 0 representing no deficit and 1 representing the full deficit. The total Frailty Index score will be calculated by dividing the sum of the variables' recoded values (the sum of the deficits) by the number of variables measured for that person. The range of the frailty index score is between 0 and 1, where higher scores indicate greater frailty.

  Assessed at baseline and at 12-month follow-up.

• Health Questionnaire - Frailty Index

  The health questionnaire includes questions related to self-rated health, chronic conditions, activities of daily living, instrumental activities of daily living, cognitive function, and mental health. Responses to each question will be coded on a scale from 0 to 1, with 0 representing no deficit and 1 representing the full deficit. The total health questionnaire Frailty Index score will be calculated by dividing the sum of the variables' coded values (the sum of the deficits) by the number of variables measured for that person. The range of the frailty index score is between 0 and 1, where higher scores indicate greater frailty.

  Baseline and 12-month follow-up.

• Clinical Frailty Scale

  The Clinical Frailty Scale (CFS) broadly stratifies degrees of fitness and frailty on a 9-point scale where higher scores indicate greater risk: 1-very fit; 2-fit; 3-managing well; 4-living with very mild frailty; 5- living with mild frailty; 6-living with moderate frailty; 7-living with severe frailty; 8- living with very severe frailty; and 9-terminally ill. The score is based on clinical judgment as part of the comprehensive geriatric assessment.

  Baseline and 12-month follow-up

• Pictorial Fit-Frail Scale

  This is a brief, picture-based frailty assessment designed so patients, caregivers, or clinicians can rate current health status common across 14 domains (e.g., mobility, function, cognition, mood, nutrition, comorbidity) using simple visual panels. This scale will be completed separately by participants (self-administered version) and health care professionals (PFFS-HCP). For each domain, the level representing least or no impairment (first picture on the left) is scored 0, the next level (second picture from the left) as 1, etc. The minimum score for each domain is 0; the maximum score for each domain ranges from 2 to 5. Total Pictorial Fit-Frail Scale scores are calculated by summing the scores across domains. The final summed score ranges from 0 (no frailty; very fit) to 43 (severely frail).

  Baseline and 12-month follow-up.

• Physical Activity Scale for the Elderly

  The Physical Activity Scale for the Elderly (PASE) quantifies the frequency, duration, and intensity of physical activities, and sedentary time. The scale includes 10 questions that collect information about physical activities performed over the past week, including leisure activities, household activities, work, and volunteering (e.g., walking, caring for another person). The responses for each activity are used to calculate a total score. Scores range from 0 to over 400, with higher scores representing greater activity levels. The Physical Activity Scale for the Elderly will be administered by the Clinical Exercise Physiologist. It will only be administered to participants who consent to participate in the sub-study.

  Group AB: Baseline, 3 months, 6 months, and 12 months Group BA: Baseline, 6 months, 9 months, and 12 months.

• Patient acceptability of eCGA

  Acceptability of the electronic Comprehensive Geriatric Assessment (eCGA) as reported by participants using an 18-item survey administered post-CGA to assess ease of completion, understanding, perceived usefulness, and overall satisfaction. Each item is scored on a 5-point Likert scale where 1 indicates strong agreement and 5 indicates strong disagreement. The acceptability score will be calculated by summing all item scores. The total score will range from 18 (best outcome) to 90 (worst outcome).

  Baseline with follow-up at 12-months.

Secondary Outcomes (6)

• Goal Attainment (PAHA Sub-Study)

  Group AB: Baseline with follow-up at 3-, 6-, and 12-months. Group BA: Baseline with follow-up at 6-, 9-, and 12-months.

• Qualitative experience of the eCGA and PAHA

  Interviews conducted approximately 12 months after baseline.

• Number of falls and fractures

  At 12-month follow-up.

• Transition to institution or higher level of care

  At 12-month follow-up

• Hospital and Emergency Department admissions

  At 12-month follow-up

Study Arms (2)

Group AB - immediate exercise group

EXPERIMENTAL

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.

Behavioral: Personalized Approach for Healthy Aging (PAHA)

Group BA - 6-month delayed exercise group

ACTIVE COMPARATOR

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.

Behavioral: Personalized Approach for Healthy Aging (PAHA)

Interventions

Personalized Approach for Healthy Aging (PAHA) 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 AB - immediate exercise group; Group BA - 6-month delayed exercise group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Nova Scotia Health Authority: lead

MeSH Terms

Conditions

Frailty; Mobility Limitation; Sedentary Behavior

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Behavior

Study Officials

• Barry Clarke, MD

  Nova Scotia Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jodie Penwarden, MFSGN

CONTACT

902-473-7705; Jodie.Penwarden@nshealth.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: Randomized, delayed-start, parallel design comparing immediate versus delayed personalized physical activity intervention.

Study Record Dates

• First Submitted: December 17, 2025
• First Posted: January 14, 2026
• Study Start: January 12, 2026
• Primary Completion (Estimated): July 12, 2027
• Study Completion (Estimated): January 12, 2029
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share