Health BehaviorNCT01841853
RCT of Health-promoting Intervention for Older Foreign-born Adults
A study testing Senior meetings in people with Health Behavior, run by Göteborg University at 1 site in Sweden.
Trial 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). Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Behavior
- What is being tested?
- Senior meetings
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- 1 siteSweden
- Study dates
- Aug 2012to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- Impaired cognition, Mini Mental State Examination (MMSE) below 80% of administered items
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Livslots Angered - A Randomized Controlled Trial of a Community-based Health-promoting and Disease-preventive Program for Older Foreign Born Adults
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.
- Conditions
- Health Behavior
- Being tested
- Senior meetings
- Keywords
- Elderly, Health promotion, Randomized controlled study, Immigrant, Vulnerable population, ADL, KASAM, Implementation
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Senior meetingsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Senior meetings | Experimental | 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. Receives: Behavioral: Senior meetings |
| Control group | No intervention | The control group will receive conventional care on their own initiative. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Activities of Daily Life (ADL)
The ADL-staircase
Measured: change from baseline at 6 months and 1 year
Change of Sense of Coherence (KASAM)
KASAM (by Antonovsky)
Measured: change from basline at 6 months and 1 year
Secondary outcomes (14)
Change of Fatigue
The Mob-T scale
Measured: baseline, 6 months, and 1 year
Change of Grip strength
North Coast-dynamometer
Measured: baseline, 6 months, and 1 year
Change of Physical activity
Questionnaire and Physical and domestic activity scale
Measured: basline, 6 months, and 1 year
Change of Balance
The balance scale
Measured: basline, 6 months, and 1 year
Change of Gait speed
Four-meter walking test
Measured: basline, 6 months, and 1 year
Change of Weight loss
The Göteborg Quality of Life Instrument
Measured: basline, 6 months, and 1 year
Change of Cognition
Mini Mental State Examination (MMSE)
Measured: basline, 6 months, and 1 year
Change of Visual impairment
KM-visual acuity chart
Measured: basline, 6 months, and 1 year
Change of Falls
Questionnaire
Measured: basline, 6 months, and 1 year
Change of Fear of falls
FES-I
Measured: baseline, 6 months, 1 year
Change of Illness
CIRS-G
Measured: Baline, 6 months, and 1 year
Change of Symptoms
The Göteborg Quality of Life Instrument
Measured: Basline, 6 months, and 1 year
Change of Change of Depression
GDS 20
Measured: Baseline, 6 months, and 1 year
Health-care consumption
Register data
Measured: Baseline, 6 months, and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2013 (estimated)
- Study startAug 2012
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Collaborators
- The Swedish Research Council
- Responsible party
- Sponsor
- Investigators
- Synneve Dahlin-Ivanoff, Professor, Study director, Göteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01841853
- Sponsor's protocol ID
- Livslots Angered
- Status last verified
- May 2019
- First submitted
- 10 Apr 2013
- Last updated
- 13 May 2019
- Results posted
- No
- Data monitoring committee
- No
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 25887506Lood 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
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Livslots Angered - A Randomized Controlled Trial of a Community-based Health-promoting and Disease-preventive Program for Older Foreign Born Adults
- ClinicalTrials.gov ID
- NCT01841853
- Acronym / sponsor ID
- Livslots Angered
- Conditions
- Health Behavior
- Keywords
- Elderly, Health promotion, Randomized controlled study, Immigrant, Vulnerable population, ADL, KASAM, Implementation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Collaborators
- The Swedish Research Council
- Study start
- Aug 2012
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 29 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Senior meetings | Experimental | Behavioral: Senior meetingsThe 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. |
| Control group | No intervention | –The control group will receive conventional care on their own initiative. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Impaired cognition, Mini Mental State Examination (MMSE) below 80% of administered items
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Senior meetingsThe 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. | Behavioural | Senior meetings |
Primary outcome
Change of Activities of Daily Life (ADL)
Time frame: change from baseline at 6 months and 1 year
The ADL-staircase
Change of Sense of Coherence (KASAM)
Time frame: change from basline at 6 months and 1 year
KASAM (by Antonovsky)
14 secondary outcomes
Change of Fatigue
Time frame: baseline, 6 months, and 1 year
Change of Grip strength
Time frame: baseline, 6 months, and 1 year
Change of Physical activity
Time frame: basline, 6 months, and 1 year
Change of Balance
Time frame: basline, 6 months, and 1 year
Change of Gait speed
Time frame: basline, 6 months, and 1 year
Change of Weight loss
Time frame: basline, 6 months, and 1 year
Change of Cognition
Time frame: basline, 6 months, and 1 year
Change of Visual impairment
Time frame: basline, 6 months, and 1 year
Change of Falls
Time frame: basline, 6 months, and 1 year
Change of Fear of falls
Time frame: baseline, 6 months, 1 year
Change of Illness
Time frame: Baline, 6 months, and 1 year
Change of Symptoms
Time frame: Basline, 6 months, and 1 year
Change of Change of Depression
Time frame: Baseline, 6 months, and 1 year
Health-care consumption
Time frame: Baseline, 6 months, and 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2019.
- Derived from this study: PubMed 25887506Gustafsson 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.
- Derived from this study: PubMed 25810033Lood 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Synneve Dahlin-Ivanoff, Professor study director
Göteborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Senior meetings in people with Health Behavior, run by Göteborg University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Activities of Daily Life (ADL) (time frame: change from baseline at 6 months and 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01841853, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2019.