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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ISRCTN
Last refreshed on: 1 November 2021
Main ID:  ISRCTN16172390
Date of registration: 30/08/2017
Prospective Registration: Yes
Primary sponsor: University of Jyvaskylä
Public title: Promoting wellbeing through active ageing
Scientific title: The effect of individualized counselling on promoting active ageing and wellbeing
Date of first enrolment: 20/09/2017
Target sample size: 200
Recruitment status: Completed
URL:  https://www.isrctn.com/ISRCTN16172390
Study type:  Interventional
Study design:  Single-centre single-blind randomized controlled trial (Quality of life)  
Phase:  Not Applicable
Countries of recruitment
Finland
Contacts
Name: Taina    Rantanen
Address:  PO Box 35 University of Jyvaskyla FI-40014 Jyväskylä Finland
Telephone: +358 (0)40 805 3590
Email: taina.rantanen@jyu.fi
Affiliation: 
Name:    
Address: 
Telephone:
Email:
Affiliation: 
Key inclusion & exclusion criteria
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

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


Age minimum:
Age maximum:
Gender: Both
Health Condition(s) or Problem(s) studied
Active ageing and wellbeing
Not Applicable
Intervention(s)

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
Primary Outcome(s)
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(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
Secondary ID(s)
The European Research Council Grant Agreement 693045 AGNES
Source(s) of Monetary Support
European Research Council
Secondary Sponsor(s)
Ethics review
Status:
Approval date:
Contact:
Central Finland Health Care District Ethical Committee, 23/08/2017, Protocol No 7/2017
Results
Results available: Yes
Date Posted:
Date Completed: 30/09/2019
URL:
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