Promoting wellbeing through active ageing

ISRCTN	ISRCTN16172390
DOI	https://doi.org/10.1186/ISRCTN16172390
Protocol serial number	The European Research Council Grant Agreement 693045 AGNES
Sponsor	University of Jyvaskylä
Funder	European Research Council

Submission date: 30/08/2017
Registration date: 30/08/2017
Last edited: 19/10/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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 or 80 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

Contact information

Prof Taina Rantanen
Scientific

PO Box 35
University of Jyvaskyla
Jyväskylä
FI-40014
Finland

ORCID ID	0000-0002-1604-1945
Phone	+358 (0)40 805 3590
Email	taina.rantanen@jyu.fi

Study information

Primary study design	Interventional
Study design	Single-centre single-blind randomized controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	The effect of individualized counselling on promoting active ageing and wellbeing
Study acronym	AGNES-PROMO
Study objectives	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(s)	Central Finland Health Care District Ethical Committee, 23/08/2017, Protocol No 7/2017
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Active ageing, measured using the University of Jyväskylä Active Aging scale (UJACAS) pre-trial, at 6 months and at 12 months (post-trial)
Key secondary outcome measure(s)	Current secondary outcome measures as of 30/05/2018: 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 7. Personal goals studied with an open-ended question modified from the Personal Project Analysis 8. Autonomy in outdoor mobility assessed with the ‘autonomy outdoors’ subscale of the Impact on Participation and Autonomy questionnaire Previous 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
Completion date	30/09/2019

Eligibility

Participant type(s)	Healthy volunteer
Age group	Senior
Sex	All
Target sample size at registration	200
Total final enrolment	204
Key inclusion criteria	Current inclusion criteria as of 30/05/2018: 1. Living independently in the community 2. Aged 75 or 80 years 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 Previous 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
Key exclusion criteria	1. Mini-Mental State Examination score (MMSE) of 24 or lower 2. Unwillingness to participate
Date of first enrolment	20/09/2017
Date of final enrolment	19/06/2018

Locations

Countries of recruitment

Finland

Study participating centre

Gerontology Research Center, Faculty of Sport and Health Sciences, University of Jyväskylä

PO Box 35 (viv)
Jyväskylä
Fi-40014
Finland

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
IPD sharing plan	The data sharing plans for the current study are unknown and will be made available at a later date.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		01/04/2020	19/10/2021	Yes	No
Results article		07/01/2019	19/10/2021	Yes	No
Results article	Secondary analyses	10/06/2020	19/10/2021	Yes	No
Protocol article	protocol	07/01/2019		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

19/10/2021: Publication references and total final enrolment number added.
09/01/2019: Publication reference added.
08/01/2019: The following changes have been made:
1. The recruitment end date has been updated from 31/12/2018 to 19/06/2018.
2. The overall trial end date has been updated from 31/12/2019 to 30/09/2019.
3. The intention to publish date has been updated from 31/12/2020 to 30/09/2020.
30/05/2018: The following changes have been made:
1. The participant inclusion criteria have been changed.
2. The secondary outcome measures have been changed.
3. The plain English summary has been changed to reflect the changes above.