Main
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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:
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ISRCTN |
Last refreshed on:
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1 November 2021 |
Main ID: |
ISRCTN16172390 |
Date of registration:
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30/08/2017 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Promoting wellbeing through active ageing
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Scientific title:
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The effect of individualized counselling on promoting active ageing and wellbeing |
Date of first enrolment:
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20/09/2017 |
Target sample size:
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200 |
Recruitment status: |
Completed |
URL:
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https://www.isrctn.com/ISRCTN16172390 |
Study type:
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Interventional |
Study design:
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Single-centre single-blind randomized controlled trial (Quality of life)
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Phase:
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Not Applicable
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Countries of recruitment
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Finland
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Contacts
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Name:
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Taina
Rantanen |
Address:
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PO Box 35
University of Jyvaskyla
FI-40014
Jyväskylä
Finland |
Telephone:
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+358 (0)40 805 3590 |
Email:
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taina.rantanen@jyu.fi |
Affiliation:
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Active ageing and wellbeing Not Applicable
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Intervention(s)
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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
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Primary Outcome(s)
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Active ageing, measured using the University of Jyväskylä Active Aging scale (UJACAS) pre-trial, at 6 months and at 12 months (post-trial)
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Secondary Outcome(s)
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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
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Secondary ID(s)
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The European Research Council Grant Agreement 693045 AGNES
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Source(s) of Monetary Support
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European Research Council
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Ethics review
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Status:
Approval date:
Contact:
Central Finland Health Care District Ethical Committee, 23/08/2017, Protocol No 7/2017
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Results
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Results available:
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Yes |
Date Posted:
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Date Completed:
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30/09/2019 |
URL:
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