AgingTech-RetiredNCT04422704
A Technology-based Intervention With Retired People
A study testing Technology-based-Intervention in people with Aging and Retirement, run by Laura Nieto Riveiro at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 61 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging, Retirement
- What is being tested?
- Technology-based-Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2017to 1 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 61 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Aging, Retirement
- Being tested
- Technology-based-Intervention
- Keywords
- Older adults, Technological devices, Technology, Healthy Lifestyle, Quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technology-based-InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Retired people | Experimental | People who are either ordinarily or early retired and who have previously held a paid employment. Receives: Behavioral: Technology-based-Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in quality of life
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.
Measured: Baseline and immediately after intervention (two months)
Secondary outcomes (4)
Behavioural adopted in terms of retirement
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.
Measured: One month before intervention
Changes in behavioural adopted in terms of retirement
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.
Measured: Baseline and immediately after intervention (two months)
Individual-interviews
To know the individual experience about the stage before retirement, the moment of retirement, the present life, future expectations and the meaning of retirement.
Measured: One month before intervention
Group-interviews
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.
Measured: Immediately after intervention (1 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start1 Jan 2017
- Primary completion1 Jun 2017
- Study completion1 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laura Nieto Riveiro
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Laura Nieto Riveiro, Universidade da Coruña
- Investigators
- Laura Nieto-Riveiro, PhD, Principal investigator, Universidade da Coruña
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04422704
- Sponsor's protocol ID
- 2016/576
- Acronym
- Tech-Retired
- Status last verified
- Oct 2020
- First submitted
- 3 May 2020
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Ye B, Chen H, Huang L, Ruan Y, Qi S, Guo Y, Huang Z, Sun S, Chen X, Shi Y, Gao J, Jiang Y. Changes in frailty among community-dwelling Chinese older adults and its predictors: evidence from a two-year longitudinal study. BMC Geriatr. 2020 Apr 10;20(1):130. doi: 10.1186/s12877-020-01530-x.
PubMed 32272903Gschwind YJ, Eichberg S, Ejupi A, de Rosario H, Kroll M, Marston HR, Drobics M, Annegarn J, Wieching R, Lord SR, Aal K, Vaziri D, Woodbury A, Fink D, Delbaere K. ICT-based system to predict and prevent falls (iStoppFalls): results from an international multicenter randomized controlled trial. Eur Rev Aging Phys Act. 2015 Nov 27;12:10. doi: 10.1186/s11556-015-0155-6. eCollection 2015.
PubMed 26865874Hamm JM, Heckhausen J, Shane J, Lachman ME. Risk of cognitive declines with retirement: Who declines and why? Psychol Aging. 2020 May;35(3):449-457. doi: 10.1037/pag0000453. Epub 2020 Mar 16.
PubMed 32175753Atchley RC. Adjustment to loss of job at retirement. Int J Aging Hum Dev. 1975;6(1):17-27. doi: 10.2190/EHU3-VCRV-VCRJ-04NU.
PubMed 1150332Atchley RC. The meaning of retirement. J Commun. 1974 Autumn;24(4):97-100. doi: 10.1111/j.1460-2466.1974.tb00414.x. No abstract available.
PubMed 4448858Park BH, Lee MS, Hong JY, Bae SH, Kim EY, Kim KK, Kim DK. The stages of physical activity and exercise behavior: an integrated approach to the theory of planned behavior. Asia Pac J Public Health. 2009 Jan;21(1):71-83. doi: 10.1177/1010539508327089. Epub 2008 Nov 17.
PubMed 19124338Pazzim TA, Marin AH. Retirement preparation program: evaluation of results. Psicol Reflex Crit. 2017 Dec 8;30(1):24. doi: 10.1186/s41155-017-0079-3.
PubMed 32026182Greig A, Dawes D, Murphy S, Parker G, Loveridge B. Program evaluation of a model to integrate internationally educated health professionals into clinical practice. BMC Med Educ. 2013 Oct 11;13:140. doi: 10.1186/1472-6920-13-140.
PubMed 24119470Ballesteros S, Kraft E, Santana S, Tziraki C. Maintaining older brain functionality: A targeted review. Neurosci Biobehav Rev. 2015 Aug;55:453-77. doi: 10.1016/j.neubiorev.2015.06.008. Epub 2015 Jun 6.
PubMed 26054789Hessel P. Does retirement (really) lead to worse health among European men and women across all educational levels? Soc Sci Med. 2016 Feb;151:19-26. doi: 10.1016/j.socscimed.2015.12.018. Epub 2015 Dec 15.
PubMed 26773290Brown RT, Diaz-Ramirez LG, Boscardin WJ, Lee SJ, Steinman MA. Functional Impairment and Decline in Middle Age: A Cohort Study. Ann Intern Med. 2017 Dec 5;167(11):761-768. doi: 10.7326/M17-0496. Epub 2017 Oct 31.
PubMed 29132150Klugar M, Cap J, Klugarova J, Mareckova J, Roberson DN, Kelnarova Z. The personal active aging strategies of older adults in Europe: a systematic review of qualitative evidence. JBI Database System Rev Implement Rep. 2016 May;14(5):193-257. doi: 10.11124/JBISRIR-2016-002393.
PubMed 27532471Damant J, Knapp M, Freddolino P, Lombard D. Effects of digital engagement on the quality of life of older people. Health Soc Care Community. 2017 Nov;25(6):1679-1703. doi: 10.1111/hsc.12335. Epub 2016 Feb 25.
PubMed 26919220
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mixed Study on the Impact of a Technology-based Intervention With Retired People
- ClinicalTrials.gov ID
- NCT04422704
- Acronym / sponsor ID
- Tech-Retired / 2016/576
- Conditions
- Aging, Retirement
- Keywords
- Older adults, Technological devices, Technology, Healthy Lifestyle, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Laura Nieto RiveiroUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jun 2017 (actual)
- Study completion
- 1 Jun 2017 (actual)
- First posted
- 9 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Retired people | Experimental | Behavioral: Technology-based-InterventionPeople who are either ordinarily or early retired and who have previously held a paid employment. |
Who may qualify
- Ages
- 61 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Technology-based-InterventionThe 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. | Behavioural | Retired people |
Primary outcome
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.
4 secondary outcomes
Behavioural adopted in terms of retirement
Time frame: One month before intervention
Changes in behavioural adopted in terms of retirement
Time frame: Baseline and immediately after intervention (two months)
Individual-interviews
Time frame: One month before intervention
Group-interviews
Time frame: Immediately after intervention (1 month)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Background: PubMed 32272903Ye B, Chen H, Huang L, Ruan Y, Qi S, Guo Y, Huang Z, Sun S, Chen X, Shi Y, Gao J, Jiang Y. Changes in frailty among community-dwelling Chinese older adults and its predictors: evidence from a two-year longitudinal study. BMC Geriatr. 2020 Apr 10;20(1):130. doi: 10.1186/s12877-020-01530-x.
- Background: PubMed 26865874Gschwind YJ, Eichberg S, Ejupi A, de Rosario H, Kroll M, Marston HR, Drobics M, Annegarn J, Wieching R, Lord SR, Aal K, Vaziri D, Woodbury A, Fink D, Delbaere K. ICT-based system to predict and prevent falls (iStoppFalls): results from an international multicenter randomized controlled trial. Eur Rev Aging Phys Act. 2015 Nov 27;12:10. doi: 10.1186/s11556-015-0155-6. eCollection 2015.
- Background: PubMed 32175753Hamm JM, Heckhausen J, Shane J, Lachman ME. Risk of cognitive declines with retirement: Who declines and why? Psychol Aging. 2020 May;35(3):449-457. doi: 10.1037/pag0000453. Epub 2020 Mar 16.
- Background: PubMed 1150332Atchley RC. Adjustment to loss of job at retirement. Int J Aging Hum Dev. 1975;6(1):17-27. doi: 10.2190/EHU3-VCRV-VCRJ-04NU.
- Background: PubMed 4448858Atchley RC. The meaning of retirement. J Commun. 1974 Autumn;24(4):97-100. doi: 10.1111/j.1460-2466.1974.tb00414.x. No abstract available.
- Background: PubMed 19124338Park BH, Lee MS, Hong JY, Bae SH, Kim EY, Kim KK, Kim DK. The stages of physical activity and exercise behavior: an integrated approach to the theory of planned behavior. Asia Pac J Public Health. 2009 Jan;21(1):71-83. doi: 10.1177/1010539508327089. Epub 2008 Nov 17.
- Background: PubMed 32026182Pazzim TA, Marin AH. Retirement preparation program: evaluation of results. Psicol Reflex Crit. 2017 Dec 8;30(1):24. doi: 10.1186/s41155-017-0079-3.
- Background: PubMed 24119470Greig A, Dawes D, Murphy S, Parker G, Loveridge B. Program evaluation of a model to integrate internationally educated health professionals into clinical practice. BMC Med Educ. 2013 Oct 11;13:140. doi: 10.1186/1472-6920-13-140.
- Background: PubMed 26054789Ballesteros S, Kraft E, Santana S, Tziraki C. Maintaining older brain functionality: A targeted review. Neurosci Biobehav Rev. 2015 Aug;55:453-77. doi: 10.1016/j.neubiorev.2015.06.008. Epub 2015 Jun 6.
- Background: PubMed 26773290Hessel P. Does retirement (really) lead to worse health among European men and women across all educational levels? Soc Sci Med. 2016 Feb;151:19-26. doi: 10.1016/j.socscimed.2015.12.018. Epub 2015 Dec 15.
- Background: PubMed 29132150Brown RT, Diaz-Ramirez LG, Boscardin WJ, Lee SJ, Steinman MA. Functional Impairment and Decline in Middle Age: A Cohort Study. Ann Intern Med. 2017 Dec 5;167(11):761-768. doi: 10.7326/M17-0496. Epub 2017 Oct 31.
- Background: PubMed 27532471Klugar M, Cap J, Klugarova J, Mareckova J, Roberson DN, Kelnarova Z. The personal active aging strategies of older adults in Europe: a systematic review of qualitative evidence. JBI Database System Rev Implement Rep. 2016 May;14(5):193-257. doi: 10.11124/JBISRIR-2016-002393.
- Official page of EuroQol Group who create the Quality of Life test.Link provided by the sponsor.
- Retired people association.Link provided by the sponsor.
- Brief Intervention in Preparation for Retirement.Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Nieto-Riveiro, PhD principal investigator
Universidade da Coruña
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Technology-based-Intervention in people with Aging and Retirement, run by Laura Nieto Riveiro at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in quality of life (time frame: Baseline and immediately after intervention (two months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04422704, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020.