GoalNav® Clinic Module - Pilot Trial

This is a pilot study to test the feasibility of GoalNav® Clinic, an Electronic Data Capture platform which is specifically designed to collect data on patient goals, live in a clinical setting.

Study Overview

• Status: Completed
• Conditions: Geriatric Assessment
• Intervention / Treatment: Behavioral: Goal Attainment Scaling (GAS) with a goal inventory; Behavioral: Goal Attainment Scaling (GAS) without inventory

Detailed Description

Goal Attainment Scaling (GAS) is an individualized outcome measure that quantifies the effects of an intervention based on personalized goals.

Ardea Outcomes has developed an electronic data capture system called GoalNav® Clinic that is designed to capture GAS data (individual goals) in addition to other outcome measures that is useful to the doctor such as assessment information, patient demographics, cognitive status, etc..

With the help of a study doctor and/or a member of the research team trained in the process of conducting GAS interviews, patients and/or care partners set goals that are meaningful and relevant to them or their loved one's condition. Goals are then followed up in three months, and ratings are provided by the GAS interviewer and patient and/or care partner.

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Nova Scotia
    • Cape Breton, Nova Scotia, Canada, B1M 0A1
      • Geriatric Medicine & Memory Disability Clinic, Cape Breton Regional Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• a new or returning patient who has been referred and has a pre-scheduled appointment to the study doctor's clinic for a geriatric assessment
• of any age, with or without a disease diagnosis/memory complaint
• the patient is accompanied by a family member or friend who is willing to participate
• the patient and/or their care partner must be able to respond to questions in English
• the patient and their care partner give informed consent

Exclusion Criteria:

• the patient does not have a family member or friend who is willing to participate
• neither the patient nor their care partner can respond to questions in English
• either or both the patient and care partner decline to provide informed consent
• the study doctor deems that the patient and/or care partner is not suitable for the study
• either the patient or their care partner indicates on the informed consent form that they do not wish to be contacted by email or by telephone

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A - Inventory; Goal Attainment Scaling (GAS) with goal inventory	Behavioral: Goal Attainment Scaling (GAS) with a goal inventory; Goal Attainment Scaling (GAS) with a goal inventory (list of common goals) as a behavioral interventional tool
Active Comparator: Arm B - No Inventory; Goal Attainment Scaling (GAS) without goal inventory	Behavioral: Goal Attainment Scaling (GAS) without inventory; Goal Attainment Scaling (GAS) without a goal inventory (list of common goals) as a behavioral interventional tool

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Goal Setting Survey	The goal setting survey includes multiple choice, Likert type and open-ended questions with respect to the feasibility and acceptability of Goal Attainment Scaling. The questions focus on the impressions and experiences of patients and care partners (in Arm A and Arm B), and the study doctors when conducting interviews using GoalNav® EDC with and without goal inventory. The percentage of participants agreeing with statements with respect to ease of use, time commitment, etc. will be the unit of measurement. The answers to the open-ended questions will also be qualitatively analyzed.	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
GAS Interviewer Individual Qualitative Interview	The one-hour qualitative interview with GAS interviewers will include questions such as; did GAS interviewers use the goal inventory for participants in Arm B (no goal inventory)?; was there a difference between Arm A and Arm B in the goal setting process?; was there a difference between Arm A and Arm B in goal quality?; did patients and care partners in Arm B find it difficult to identify challenges or goal areas without sufficient prompts?	4 months

Collaborators and Investigators

• Sponsor: Ardea Outcomes
• Collaborators: National Research Council, Canada
• Investigators: Principal Investigator: Arlene Kelly-Wiggins, MD, Nova Scotial Health

Publications and helpful links

General Publications

• Kiresuk TJ, Sherman RE. Goal attainment scaling: A general method for evaluating comprehensive community mental health programs. Community Ment Health J. 1968 Dec;4(6):443-53. doi: 10.1007/BF01530764.

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2023
• Primary Completion (Actual): November 30, 2024
• Study Completion (Actual): November 30, 2024

Study Registration Dates

• First Submitted: August 9, 2023
• First Submitted That Met QC Criteria: August 24, 2023
• First Posted (Actual): August 31, 2023

Study Record Updates

• Last Update Posted (Estimated): September 24, 2025
• Last Update Submitted That Met QC Criteria: September 19, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: GoalNavRCC2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No