ClinicalTrials.gg
CompletedNCT01841853Updated May 13, 2019

RCT of Health-promoting Intervention for Older Foreign-born Adults

An interventional study of Senior meetings in Health Behavior, sponsored by Göteborg University. Completed at 1 site in Sweden. Open to participants aged 70 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-05-13.

Sponsored by Göteborg University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
131
Allocation
Randomized
Ages
70 Years and older
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Health Behavior

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Keywords

  • Elderly
  • Health promotion
  • Randomized controlled study
  • Immigrant
  • Vulnerable population
  • ADL
  • KASAM
  • Implementation
03

In context

Health Behavior

249 studies on the registry are indexed under Health Behavior; 98 are open to participants now.

This study's enrollment of 131 is close to the median of 120 across 213 interventional studies indexed under Health Behavior.

Browse Health Behavior studies →

Lead sponsor

Göteborg University is the lead sponsor of 270 studies on the registry; 47 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
70 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Impaired cognition, Mini Mental State Examination (MMSE) below 80% of administered items
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
131 participants (actual)

Study arms

  • 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.

    Behavioral: Senior meetings

  • No intervention
    Control group

    The control group will receive conventional care on their own initiative.

Interventions

  • BehavioralSenior meetings

    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.

06

What researchers measure

Primary outcomes

  1. Change of Activities of Daily Life (ADL)

    The ADL-staircase

    Time frame: change from baseline at 6 months and 1 year

  2. Change of Sense of Coherence (KASAM)

    KASAM (by Antonovsky)

    Time frame: change from basline at 6 months and 1 year

Secondary outcomes

  1. Change of Fatigue

    The Mob-T scale

    Time frame: baseline, 6 months, and 1 year

  2. Change of Grip strength

    North Coast-dynamometer

    Time frame: baseline, 6 months, and 1 year

  3. Change of Physical activity

    Questionnaire and Physical and domestic activity scale

    Time frame: basline, 6 months, and 1 year

  4. Change of Balance

    The balance scale

    Time frame: basline, 6 months, and 1 year

  5. Change of Gait speed

    Four-meter walking test

    Time frame: basline, 6 months, and 1 year

  6. Change of Weight loss

    The Göteborg Quality of Life Instrument

    Time frame: basline, 6 months, and 1 year

  7. Change of Cognition

    Mini Mental State Examination (MMSE)

    Time frame: basline, 6 months, and 1 year

  8. Change of Visual impairment

    KM-visual acuity chart

    Time frame: basline, 6 months, and 1 year

  9. Change of Falls

    Questionnaire

    Time frame: basline, 6 months, and 1 year

  10. Change of Fear of falls

    FES-I

    Time frame: baseline, 6 months, 1 year

  11. Change of Illness

    CIRS-G

    Time frame: Baline, 6 months, and 1 year

  12. Change of Symptoms

    The Göteborg Quality of Life Instrument

    Time frame: Basline, 6 months, and 1 year

  13. Change of Change of Depression

    GDS 20

    Time frame: Baseline, 6 months, and 1 year

  14. Health-care consumption

    Register data

    Time frame: Baseline, 6 months, and 1 year

07

Study locations

1 site
  • Synneve Dahlin-Ivanoff
    Gothenburg, 40530, Sweden
08

References and documents

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. PubMed 25887506 ↗
  • 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. PubMed 25810033 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Aug 2012, a primary completion of Jan 2016 and a completion of Jan 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 10, 2013
First posted
Apr 29, 2013
Start
Aug 2012
Primary completionActual
Jan 2016
CompletionActual
Jan 2016
Last update
May 13, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 13, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01841853
Collaborators
The Swedish Research Council
Responsible party
Sponsor
First posted
Apr 29, 2013
Start date
Aug 2012
Primary completion
Jan 2016
Completion
Jan 2016
Last update
May 13, 2019

Study contacts

Synneve Dahlin-Ivanoff, Professor
study director · Göteborg University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.

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