Condition category
Not Applicable
Date applied
30/08/2017
Date assigned
30/08/2017
Last edited
30/08/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
All too often, policy makers consider active ageing as disability prevention and a way to save on health and social care budgets. Such an approach represents older people as a burden for society thus raising the risk of discrimination and so-called "ageism". In this study active ageing is defined as an interplay between ability, activity, ambition and autonomy. Based on this approach a counselling intervention will be developed to promote active ageing with the older people's own activity goals as the starting point. The aim of this study is to assess the effect of individualized counselling on promoting active ageing and wellbeing.

Who can participate?
Older people aged 75, 80 and 85 who live independently in the community in the City of Jyväskylä with moderate levels of physical activity

What does the study involve?
Participants are randomly allocated to either the intervention group or the control group. The control group receive written general health information. Over 12 months participants in the intervention group receive individually tailored counselling in a face-to-face session and phone calls. During the face-to-face counselling session, participants are encouraged to set goals according to their interests regarding activities and behaviours that they would like to introduce to or increase in their everyday life. During the follow up phone calls they discuss their progress on achieving their goals, share their successes, failures, and are encouraged to continue their efforts towards active ageing. During the first face-to-face counselling session, an information booklet regarding active ageing activities and behaviours and a Newsletter is given to them. The information booklet includes tips and self-help exercises to be used as an additional support.

What are the possible benefits and risks of participating?
Participants may benefit from receiving practical information on ways to promote their well-being through active agency based on their goals. By participating in this study, participants help researchers to better understand active aging and well-being and to find ways to promote active aging and well-being. Eventually, this and other studies in this area may provide opportunities to change the recommendations for health promotion of older people and impact policies. The interviews, tests and intervention do not exceed the strain of daily life and no other side effects are expected.

Where is the study run from?
University of Jyväskylä (Finland)

When is the study starting and how long is it expected to run for?
January 2017 to December 2019

Who is funding the study?
European Research Council

Who is the main contact?
Prof. Taina Rantanen
taina.rantanen@jyu.fi

Trial website

Contact information

Type

Scientific

Primary contact

Prof Taina Rantanen

ORCID ID

http://orcid.org/0000-0002-1604-1945

Contact details

PO Box 35
University of Jyvaskyla
Jyväskylä
FI-40014
Finland
+358 (0)40 805 3590
taina.rantanen@jyu.fi

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

The European Research Council Grant Agreement 693045 AGNES

Study information

Scientific title

The effect of individualized counselling on promoting active ageing and wellbeing

Acronym

AGNES-PROMO

Study hypothesis

To develop and test feasibility and effectiveness of a multicomponent sustainable individually tailored counselling intervention aiming to promote active ageing in community-dwelling older people. The overall goal of the counseling intervention is to promote active ageing, that is, any participation in valued life activities. Current evidence suggests that physical, social, cultural and generative activities predict more favorable health trajectories among older people. Individualized counselling supporting the autonomy and agency of the participants in striving for their individualized goals will increase active ageing and wellbeing.

Ethics approval

Central Finland Health Care District Ethical Committee, 23/08/2017, Protocol No 7/2017

Study design

Single-centre single-blind randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Home

Trial type

Quality of life

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Active ageing and wellbeing

Intervention

The overall goal of the 12-month counseling intervention is to promote active aging, that is, any participation in valued life activities. The intervention development is based on the COM-B model and the Behavior Change Wheel framework. The Self-determination theory and the Theory of Planned behavior are the two theoretical frameworks that their constructs are used as hypothesized mechanisms that will be activated to produce the expected changes. A health information group will function as control group.

Participants will be randomized to intervention or control group following the baseline assessments using a computer generated randomization scheme, which is stratified by age and sex.

The counseling intervention condition includes a face-to-face counselling session and 4 follow-up counselling phone calls in month 2, 4, 6, and 9. During the face-to-face counselling session, participants will be encouraged to set goals according to their interests regarding activities and behaviors that they would like to introduce to or increase in their everyday life. During the follow up phone calls there will be a discussion regarding their progress on achieving their goals, share their successes, failures, and they will be encouraged to continue their efforts towards active ageing. During the first face-to-face counseling session, an Information Booklet regarding active ageing activities and behaviors and a Newsletter will be delivered to them. The information Booklet will include tips and self-help exercises to be used during the one year of the intervention program as an additional support. Additional newsletters will be sent by post in month 1, 3, 6, and 9 in order to increase their knowledge about available opportunities in the area of Jyvaskyla.

The health information control group will receive by post printed general health information material during months: 1, 3, 6, and 9, which is used in the usual health care services for older people. After completion of all study assessments, participants of the health information control group will receive the Information Booklet regarding active ageing activities and behaviors that counseling intervention participants received during their initial counseling session.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Active ageing, measured using the University of Jyväskylä Active Aging scale (UJACAS) pre-trial, at 6 months and at 12 months (post-trial)

Secondary outcome measures

1. Wellbeing, assessed with the Ryff scale pre- and post-trial
2. Depressive symptoms, assessed with the Center for Epidemiologic Studies Depression Scale (CES-D) pre- and post-trial
3. Quality of life, assessed using the Older People’s Quality of Life questionnaire (OPQOL-brief) pre- and post-trial
4. Autonomy in outdoor mobility, assessed using a subscale of the Impact of Participation and Autonomy scale (IPA) pre- and post-trial
5. Mobility, assessed with the University of Alabama at Birmingham Life-space mobility assessment (LSA) pre- and post-trial
6. Physical activity, assessed objectively with trial axial accelerometers and using self-reports (the Yale Physical Activity Survey for Older Adults [YAPS]) pre- and post-trial

Overall trial start date

01/01/2017

Overall trial end date

31/12/2019

Reason abandoned

Eligibility

Participant inclusion criteria

1. Living independently in the community
2. Age 75, 80 or 85
3. University of Alabama at Birmingham Life-Apace mobility Assessment (LSA) score between 52.3 - 90.0
4. No evident cognitive decline
5. Participants will be recruited from a cohort study

Participant type

Healthy volunteer

Age group

Senior

Gender

Both

Target number of participants

200, half in the intervention and half in the control condition

Participant exclusion criteria

1. Mini-Mental State Examination score (MMSE) of 24 or lower
2. Unwillingness to participate

Recruitment start date

20/09/2017

Recruitment end date

31/12/2018

Locations

Countries of recruitment

Finland

Trial participating centre

Gerontology Research Center, Faculty of Sport and Health Sciences, University of Jyväskylä
PO Box 35 (viv)
Jyväskylä
Fi-40014
Finland

Sponsor information

Organisation

University of Jyvaskylä

Sponsor details

PO Box 35
Jyvaskyla
Fi-40014
Finland

Sponsor type

University/education

Website

www.jyu.fi

Funders

Funder type

Research council

Funder name

European Research Council

Alternative name(s)

ERC

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Results and Publications

Publication and dissemination plan

Study protocol will be published in 2018. The knowledge produced by this project is communicated to the scientific community through articles published in international scientific journals and presentations in scientific and professional congresses. The trialists prioritize open access publishing and comply with the JyU recommendation for parallel publishing in the open access digital JYX repository. They will inform the general public about the research results through traditional and social media. After the end of the intervention, the effects on the main outcome will be reported in an international peer-reviewed journal during the year 2020. Publications on secondary outcomes will follow in 2020-2022.

IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/12/2020

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes