Clinical trial NCT01841853: RCT of Health-promoting Intervention for Older Foreign-born Adults
Official title: Livslots Angered - A Randomized Controlled Trial of a Community-based Health-promoting and Disease-preventive Program for Older Foreign Born Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Behavior
Keywords: Elderly
Health promotion
Randomized controlled study
Immigrant
Vulnerable population
ADL
KASAM
Implementation
Lead sponsor: Göteborg University
Sponsor class: OTHER
Collaborators: name: The Swedish Research Council
First posted: 2013-04-29
Enrollment: 131
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The overarching aim with this study was to develop, implement and evaluate a health promoting programme for people from Finland or the Western Balkan region, who were 70 years of age or older and independent daily activites (1). The aim of the programme was to prevent or delay dependence in daily activities, health decline, and frailty. The study focused on both evaluation and implementation and the data collection finished in 2016

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of Activities of Daily Life (ADL)
timeFrame: change from baseline at 6 months and 1 year
measure: Change of Sense of Coherence (KASAM)
timeFrame: change from basline at 6 months and 1 year
Secondary outcomes:
measure: Change of Fatigue
timeFrame: baseline, 6 months, and 1 year
measure: Change of Grip strength
timeFrame: baseline, 6 months, and 1 year
measure: Change of Physical activity
timeFrame: basline, 6 months, and 1 year
measure: Change of Balance
timeFrame: basline, 6 months, and 1 year
measure: Change of Gait speed
timeFrame: basline, 6 months, and 1 year
measure: Change of Weight loss
timeFrame: basline, 6 months, and 1 year
measure: Change of Cognition
timeFrame: basline, 6 months, and 1 year
measure: Change of Visual impairment
timeFrame: basline, 6 months, and 1 year
measure: Change of Falls
timeFrame: basline, 6 months, and 1 year
measure: Change of Fear of falls
timeFrame: baseline, 6 months, 1 year
measure: Change of Illness
timeFrame: Baline, 6 months, and 1 year
measure: Change of Symptoms
timeFrame: Basline, 6 months, and 1 year
measure: Change of Change of Depression
timeFrame: Baseline, 6 months, and 1 year
measure: Health-care consumption
timeFrame: Baseline, 6 months, and 1 year
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Synneve Dahlin-Ivanoff
Study officials:
affiliation: Göteborg University
name: Synneve Dahlin-Ivanoff, Professor
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.