Motivational Evaluation and Intervention With Co-Adapt Application for Healthy Ageing

NCT05116553 | Completed

• 1 other identifier: COADAPT 2021 T-6.4
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to identify effective methodologies to help people to improve their awareness of change, motivation, self-confidence and self-efficacy, compliance in behavioral change and psychological well-being.

Conditions

Motivation; Self Efficacy

Keywords

Motivation; Self efficacy

Outcome Measures

Primary Outcomes (2)

• Change in levels of General Self-Efficacy Scale-10 (GSE-10)

  GSE-10 test is a validated test for the detection of general self efficacy. The total score ranges from 10 to 40. Higher scores mean better outcomes.

  Up to day 14

• Change in levels of Basic Psychological Need Satisfaction and Frustration Scale (BPNSFS)

  The BPNSFP-24 test is a validated test for the detection of the satisfaction and frustration of the primary needs: autonomy, relatedness and competence (according to SDT Theory). The total score ranges from 24 to 120. Higher scores mean better outcomes.

  Up to day 14

Secondary Outcomes (2)

• Change of the scales contained in the Depression Anxiety Stress Scales-21 (DASS-21)

  Up to day 14

• Change in World Health Organisation-Five Well-Being Index (WHO-5)

  Up to day 14

Study Arms (2)

SDT (MI)

ACTIVE COMPARATOR

This group will receive standard 2 SDT (Self Determination Theory) psychological interviews.

Behavioral: SDT

SDT (MI) + CA

EXPERIMENTAL

This group will receive standard 2 SDT (Self Determination Theory) psychological interviews; moreover they will use an APP with a CA (Conversational Agent), an Artificial Intelligence.

Behavioral: SDT; Device: APP + CA

Interventions

SDT BEHAVIORAL

Standard 2 SDT (Self Determination Theory) psychological interviews.

SDT (MI); SDT (MI) + CA

APP + CA DEVICE

An APP with a CA (Conversational Agent).

SDT (MI) + CA

Eligibility Criteria

• Age: 50 Years - 67 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• whitecollar
• a sufficient level of education to understand study procedures and be able to communicate with site personnel
• to 70 years old

You may not qualify if:

• \- current use of narcotics or other substances

Sponsors & Collaborators

• Idego srl: lead

Study Sites (1)

Idego srl

Rome, 00197, Italy

Location

Study Officials

• Tommaso Ciulli

  Idego srl

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Pre-intervention test will be administered to the participants (T1) to assess their psychological well-being, motivation, awareness of change, self-confidence and self-efficacy. Participants will be randomly divided into two group: the experimental group will receive the standard 2 Self Determination Theory (SDT) psychological interviews with the support of the APP with the Conversational Agent (CA), while the control group will receive the 2 SDT (Self Determination Theory) psychological interviews. At the end of the pathway post-intervention test (T2) will be administered to the participants with the same questionnaire of the beginning.

Study Record Dates

• First Submitted: October 26, 2021
• First Posted: November 11, 2021
• Study Start: November 11, 2021
• Primary Completion: December 31, 2021
• Study Completion: January 20, 2022
• Last Updated: January 21, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available starting in February 2022
• Access Criteria: The data available on the research website (www.co-adapt.it). A special page will be created where researchers can download the raw data to perform any analysis.

Locations

IT (1)