- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01841853
RCT of Health-promoting Intervention for Older Foreign-born Adults
Livslots Angered - A Randomized Controlled Trial of a Community-based Health-promoting and Disease-preventive Program for Older Foreign Born Adults
Study Overview
Detailed Description
The study has developed tools for collaboration between the target group, staff and researchers, as well as with tools to bridge barriers to health promotion. For example, alternative ways to recruit participants and to collect and analyse data in studies with and for people who are ageing in a migration context.
The findings describe how a person-centred approach could be used to make use of the resources of the target groups, and visualise methods to bridge linguistic barriers. The education material from Older people in the risk zone has also been translated to Bosnian Serbo-Croatian and Finnish.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Gothenburg, Sweden, 40530
- Synneve Dahlin-Ivanoff
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Foreign-born from Finland or any of five countries in the Western Balkans (Bosnia-Herzegovina, Croatia, Macedonia, Montenegro, and Serbia)
- 70 years of age or older
- Living in Angered, Gothenburg
- Living in their ordinary housing
- Not dependent on informal or formal help in daily activities
Exclusion Criteria:
- Impaired cognition, Mini Mental State Examination (MMSE) below 80% of administered items
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Senior meetings
The intervention will comprise four weekly meetings in small groups (4-6 participants) in addition to an individual follow-up home visit two to three weeks after the last senior meeting.The main purpose of the senior meetings is to give information and facilitate discussion of the ageing process and provide tools and suggest strategies to enable the clients to solve the various problems that may arise at home in order to remain living at home in a safe and secure way.
The information will also include what the municipality provides in the form of local meeting places, activities run by local associations, physical training for seniors, walking groups, possibilities of offering or accepting help on a voluntary basis.
Furthermore, they will be informed about help and support available in their city district.
Identification of risks for, and advice on, how to prevent falls will also be included.
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The intervention will be led by professionals such as a registered occupational therapist, a nurse, a physical therapist, and a social worker.
The intervention will comprise four weekly meetings in small groups (4-6 participants) in addition to an individual follow-up home visit two to three weeks after the last senior meeting.
To use groups involve the possibility of peer education where participants in a person-centeredness perspective are seen as experts on their own situation and learn from each other.
The relationship between the personnel and the participants in the senior meetings can be described as a partnership.
Respect for the participant and his/her values, and that the participant gets an opportunity to maintain and develop their own power over their own everyday activities will be essential in the meeting.
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No Intervention: Control group
The control group will receive conventional care on their own initiative.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change of Activities of Daily Life (ADL)
Time Frame: change from baseline at 6 months and 1 year
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The ADL-staircase
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change from baseline at 6 months and 1 year
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Change of Sense of Coherence (KASAM)
Time Frame: change from basline at 6 months and 1 year
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KASAM (by Antonovsky)
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change from basline at 6 months and 1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change of Fatigue
Time Frame: baseline, 6 months, and 1 year
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The Mob-T scale
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baseline, 6 months, and 1 year
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Change of Grip strength
Time Frame: baseline, 6 months, and 1 year
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North Coast-dynamometer
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baseline, 6 months, and 1 year
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Change of Physical activity
Time Frame: basline, 6 months, and 1 year
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Questionnaire and Physical and domestic activity scale
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basline, 6 months, and 1 year
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Change of Balance
Time Frame: basline, 6 months, and 1 year
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The balance scale
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basline, 6 months, and 1 year
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Change of Gait speed
Time Frame: basline, 6 months, and 1 year
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Four-meter walking test
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basline, 6 months, and 1 year
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Change of Weight loss
Time Frame: basline, 6 months, and 1 year
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The Göteborg Quality of Life Instrument
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basline, 6 months, and 1 year
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Change of Cognition
Time Frame: basline, 6 months, and 1 year
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Mini Mental State Examination (MMSE)
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basline, 6 months, and 1 year
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Change of Visual impairment
Time Frame: basline, 6 months, and 1 year
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KM-visual acuity chart
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basline, 6 months, and 1 year
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Change of Falls
Time Frame: basline, 6 months, and 1 year
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Questionnaire
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basline, 6 months, and 1 year
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Change of Fear of falls
Time Frame: baseline, 6 months, 1 year
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FES-I
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baseline, 6 months, 1 year
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Change of Illness
Time Frame: Baline, 6 months, and 1 year
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CIRS-G
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Baline, 6 months, and 1 year
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Change of Symptoms
Time Frame: Basline, 6 months, and 1 year
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The Göteborg Quality of Life Instrument
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Basline, 6 months, and 1 year
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Change of Change of Depression
Time Frame: Baseline, 6 months, and 1 year
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GDS 20
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Baseline, 6 months, and 1 year
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Health-care consumption
Time Frame: Baseline, 6 months, and 1 year
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Register data
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Baseline, 6 months, and 1 year
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Synneve Dahlin-Ivanoff, Professor, Göteborg University
Publications and helpful links
General Publications
- Gustafsson S, Lood Q, Wilhelmson K, Haggblom-Kronlof G, Landahl S, Dahlin-Ivanoff S. A person-centred approach to health promotion for persons 70+ who have migrated to Sweden: promoting aging migrants' capabilities implementation and RCT study protocol. BMC Geriatr. 2015 Feb 14;15:10. doi: 10.1186/s12877-015-0005-4.
- Lood Q, Gustafsson S, Dahlin Ivanoff S. Bridging barriers to health promotion: a feasibility pilot study of the 'Promoting Aging Migrants' Capabilities study'. J Eval Clin Pract. 2015 Aug;21(4):604-13. doi: 10.1111/jep.12345. Epub 2015 Mar 23.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Livslots Angered
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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