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

January 20, 2022 updated by: Idego srl
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Subjects involved will have the opportunity to partecipate in a two-weeks course: two SDT (Self Determination Theory) psychological interviews are scheduled (1 per week) to help the participant increase his motivation and awareness about the problem reported during the counseling session.

For this purpose, the use of an APP with a CA (Conversational Agent) will be implemented as a support to help people to identify one's thoughts and emotional states as well as increase their awareness about themselves.

Test will be administered at the beginning (T1) and at the end of the meetings (T2).

Participants will be randomly divided into one of two groups to understand whether APP and CA has a significant impact in increasing motivation and awareness of the need for a pathway with a professional.

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00197
        • Idego srl

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 67 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

- current use of narcotics or other substances

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: SDT (MI)
This group will receive standard 2 SDT (Self Determination Theory) psychological interviews.
Behavioral: SDT
Standard 2 SDT (Self Determination Theory) psychological interviews.
EXPERIMENTAL: SDT (MI) + CA
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
Standard 2 SDT (Self Determination Theory) psychological interviews.
Device: APP + CA
An APP with a CA (Conversational Agent).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in levels of General Self-Efficacy Scale-10 (GSE-10)
Time Frame: Up to day 14
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)
Time Frame: Up to day 14
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of the scales contained in the Depression Anxiety Stress Scales-21 (DASS-21)
Time Frame: Up to day 14
The DASS-21 test is a validated test for the detection of depression, anxiety and stress. The total score of each subscale ranges from 0 to 42. Higher scores mean worse outcomes.
Up to day 14
Change in World Health Organisation-Five Well-Being Index (WHO-5)
Time Frame: Up to day 14
The WHO-5 test is a validated test for the detection of psychological wellbeing. The total score ranges from 0 to 100. Higher scores mean better outcomes.
Up to day 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Idego srl

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 11, 2021

Primary Completion (ACTUAL)

December 31, 2021

Study Completion (ACTUAL)

January 20, 2022

Study Registration Dates

First Submitted

October 26, 2021

First Submitted That Met QC Criteria

November 8, 2021

First Posted (ACTUAL)

November 11, 2021

Study Record Updates

Last Update Posted (ACTUAL)

January 21, 2022

Last Update Submitted That Met QC Criteria

January 20, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • COADAPT 2021 T-6.4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Clinical data obtained from psychological testing and socio-demographic data and any feedback collected during the trial will be shared.

IPD Sharing Time Frame

Data will be available starting in February 2022

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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