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Not yet recruiting NCT07341061

Comprehensive Geriatric Assessment in Primary Care

No phase Interventional Frailty Aging Geriatric Syndromes Mobility Limitation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Personalized Approach for Healthy Aging (PAHA).
Who it may be relevant to
Registry conditions: Frailty, Aging, Geriatric Syndromes, Mobility Limitation. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Comprehensive Geriatric Assessment in Primary Care for Older Adults Across Levels of Frailty

Overview

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.

Interventions

  • Behavioral 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.

Primary outcome measures

  • Comprehensive Geriatric Assessment - Frailty Index [Time frame: Assessed at baseline and at 12-month follow-up.]
  • Health Questionnaire - Frailty Index [Time frame: Baseline and 12-month follow-up.]
  • Clinical Frailty Scale [Time frame: Baseline and 12-month follow-up]
  • Pictorial Fit-Frail Scale [Time frame: Baseline and 12-month follow-up.]
  • Physical Activity Scale for the Elderly [Time frame: Group AB: Baseline, 3 months, 6 months, and 12 months Group BA: Baseline, 6 months, 9 months, and 12 months.]
  • Patient acceptability of eCGA [Time frame: Baseline with follow-up at 12-months.]
Secondary outcome measures (6)
  • Goal Attainment (PAHA Sub-Study) [Time frame: 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 [Time frame: Interviews conducted approximately 12 months after baseline.]
  • Number of falls and fractures [Time frame: At 12-month follow-up.]
  • Transition to institution or higher level of care [Time frame: At 12-month follow-up]
  • Hospital and Emergency Department admissions [Time frame: At 12-month follow-up]
  • Number of deaths [Time frame: At 12-month follow-up]

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Health services research

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07341061 · 1032253 · 2021-1962

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗