A Technology-based Intervention With Retired People (Tech-Retired)

October 6, 2020 updated by: Laura Nieto Riveiro

Mixed Study on the Impact of a Technology-based Intervention With Retired People

The main objective of the study is to understand retired people's perception of retirement, to know their personal experience and to jointly seek solutions to the needs and problems encountered.

Secondarily, the aim is to understand the impact that an active aging program intervention implemented in retired people, based on the use of technology and considering the basis for the adaptation of the Prochaska and Diclemente Trans-Theoretical Model, can have in their quality of life.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The present study has been approached from a mixed-methods research. Mainly, the study is focused on a Research-Action-Participation method in order for empowering and to people having more control over their lives. This approach was used taking into account the many changes caused by leaving working life to begin the stage of retirement. In reference to participatory methods, techniques such as brainstorming, and consensus-building and visual techniques have been included.

The quantitative approach is a complementary method to the qualitative approach based on a quasi-experimental study, as no control group has been introduced. From this approach, a descriptive and comparative study has been carried out on quality of life and the behavior adopted in the adaptation to retirement, both measured before and after the intervention.

The intervention program developed consists of a brief-intervention about 5 sessions lasting between 45-60 minutes. It was intended to address the concerns and needs that emerge from the participants' interviews. The intervention is based on the principles of the process of adaptation to retirement defined by Atchley and the Prochaska and Diclemente Model on the phases of preparation for retirement. The material to be used will be based on existing resources for retired people, awareness through multimedia material and knowledge of possible contributions of different technological devices to healthy-lifestyle.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
31

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Spain
      • A Coruña, Spain, 15006
        • Universidade da Coruña

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

61 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • People retired recently (since 10 years maximum)
  • People who attend regularly the institution selected for recruitment, which is attended by retired people over the age of 60 years old.

Exclusion criteria:

  • People who present cognitive and psychological alterations that may interfere in the interview
  • People who have not had paid employment
  • People who have completed previously a preparation for retirement's program.

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: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Retired people
People who are either ordinarily or early retired and who have previously held a paid employment.
Behavioral: Technology-based-Intervention

The intervention is intended to address the concerns and needs that emerge from the participants' interviews. The intervention is based on the principles of the process of adaptation to retirement defined by Atchley and the Prochaska and Diclemente Model on the phases of preparation for retirement. The material to be used will be based on existing resources for retired people, awareness through multimedia material and knowledge of possible contributions of different technological devices to the retirement process.

The sessions consisted of showing different exercises and devices to perform physical activities, cognitive training, relaxation activities, counselling about healthy eating and leisure-time activities.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in quality of life
Time Frame: Baseline and immediately after intervention (two months)
EuroQol-5D: To measure the quality of life variable before and after intervention. This tool allows exploring the perception of each participant about their health status and quality of life. This scale measures three elements: A descriptive dimension divided into 5 dimensions: mobility, personal care, daily activities, pain/discomfort and anxiety/depression. The person must choose between one of the following levels of severity: 1 or absence of problems, 2 or presence of some problems, 3 or presence of serious or moderate problems. A visual analogue scale: the person indicates in a rule of 0 or worse health, to 100 or better health.
Baseline and immediately after intervention (two months)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Behavioural adopted in terms of retirement
Time Frame: One month before intervention
It was measured according to the phase in which the person is at the beginning of the intervention, be it pre-contemplation in which the person is unaware of or uninterested in preparing and training for retirement, so he or she has no intention of changing his or her behavior; contemplation in which the person is aware of the possible difficulties he or she will have to face in the retirement stage, but does not assimilate the need to change his or her behavior; or action in which the person begins to think about different ideas for retirement and puts them into practice.
One month before intervention
Changes in behavioural adopted in terms of retirement
Time Frame: Baseline and immediately after intervention (two months)
It was measured according to the phase in which the person is at the end of the intervention, be it pre-contemplation in which the person is unaware of or uninterested in preparing and training for retirement, so he or she has no intention of changing his or her behavior; contemplation in which the person is aware of the possible difficulties he or she will have to face in the retirement stage, but does not assimilate the need to change his or her behavior; or action in which the person begins to think about different ideas for retirement and puts them into practice.
Baseline and immediately after intervention (two months)
Individual-interviews
Time Frame: One month before intervention
To know the individual experience about the stage before retirement, the moment of retirement, the present life, future expectations and the meaning of retirement.
One month before intervention
Group-interviews
Time Frame: Immediately after intervention (1 month)
To know the experience at group level of how they have lived the intervention, what it has brought them, how they have felt with the technology and what sense they give to it after carrying out the intervention.
Immediately after intervention (1 month)

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Laura Nieto Riveiro

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Laura Nieto-Riveiro, PhD, Universidade da Coruña

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 3, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 9, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 8, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 6, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2016/576

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

The IPD sharing plan contains the collection of the variables extracted from the Euroqol-5D-5L scale and the sociodemographic data of the study sample, the study protocol developed, and the informed consent form used.

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.

Clinical Trials on Aging

Clinical Trials on Technology-based-Intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings