GoalNav® Clinic Module - Pilot Trial

• Sponsor: Ardea Outcomes (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06019143
• Collaborator: National Research Council, Canada (Other)
• Enrollment: 30
• Arms: 2
• Anticipated Duration (Months): 7

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Geriatric Assessment	Behavioral: Goal Attainment Scaling (GAS) with a goal inventory; Behavioral: Goal Attainment Scaling (GAS) without inventory	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: GoalNav® Clinic Module - Pilot Trial
• Anticipated Study Start Date: Aug 1, 2023
• Anticipated Primary Completion Date: Mar 1, 2024
• Anticipated Study Completion Date: Mar 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm A 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 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

Outcome Measures

Primary Outcome Measures

1. Goal Setting Survey [4 months]

   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.

Secondary Outcome Measures

1. GAS Interviewer Individual Qualitative Interview [4 months]

   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?

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Ardea Outcomes
• National Research Council, Canada

Investigators

• Principal Investigator: Arlene Kelly-Wiggins, MD, Nova Scotial Health

Study Documents (Full-Text)

None provided.

More Information

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.

• Responsible Party: Ardea Outcomes
• ClinicalTrials.gov Identifier: NCT06019143
• Other Study ID Numbers: GoalNavRCC2023
• First Posted: Aug 31, 2023
• Last Update Posted: Aug 31, 2023
• Last Verified: Aug 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Aug 31, 2023