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

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ClinicalTrials.gov Identifier: NCT01841853
Recruitment Status : Completed
First Posted : April 29, 2013
Last Update Posted : September 27, 2016
Sponsor:
Collaborators:
The Swedish Research Council
City of Gothenburg
Information provided by (Responsible Party):
Göteborg University

Brief Summary:
The aim of this research project is to evaluate a health-promoting and disease-preventive intervention for older foreign-born adults. The overarching goal of the intervention is to preserve participant's health, quality of life, and minimize their need of medical care.

Condition or disease Intervention/treatment Phase
Health Behavior Behavioral: Senior meetings Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 131 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Livslots Angered - A Randomized Controlled Trial of a Community-based Health-promoting and Disease-preventive Program for Older Foreign Born Adults
Study Start Date : August 2012
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Arm Intervention/treatment
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
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.

No Intervention: Control group
The control group will receive conventional care on their own initiative.



Primary Outcome Measures :
  1. Change of Activities of Daily Life (ADL) [ Time Frame: change from baseline at 6 months and 1 year ]
    The ADL-staircase

  2. Change of Sense of Coherence (KASAM) [ Time Frame: change from basline at 6 months and 1 year ]
    KASAM (by Antonovsky)


Secondary Outcome Measures :
  1. Change of Fatigue [ Time Frame: baseline, 6 months, and 1 year ]
    The Mob-T scale

  2. Change of Grip strength [ Time Frame: baseline, 6 months, and 1 year ]
    North Coast-dynamometer

  3. Change of Physical activity [ Time Frame: basline, 6 months, and 1 year ]
    Questionnaire and Physical and domestic activity scale

  4. Change of Balance [ Time Frame: basline, 6 months, and 1 year ]
    The balance scale

  5. Change of Gait speed [ Time Frame: basline, 6 months, and 1 year ]
    Four-meter walking test

  6. Change of Weight loss [ Time Frame: basline, 6 months, and 1 year ]
    The Göteborg Quality of Life Instrument

  7. Change of Cognition [ Time Frame: basline, 6 months, and 1 year ]
    Mini Mental State Examination (MMSE)

  8. Change of Visual impairment [ Time Frame: basline, 6 months, and 1 year ]
    KM-visual acuity chart

  9. Change of Falls [ Time Frame: basline, 6 months, and 1 year ]
    Questionnaire

  10. Change of Fear of falls [ Time Frame: baseline, 6 months, 1 year ]
    FES-I

  11. Change of Illness [ Time Frame: Baline, 6 months, and 1 year ]
    CIRS-G

  12. Change of Symptoms [ Time Frame: Basline, 6 months, and 1 year ]
    The Göteborg Quality of Life Instrument

  13. Change of Change of Depression [ Time Frame: Baseline, 6 months, and 1 year ]
    GDS 20

  14. Health-care consumption [ Time Frame: Baseline, 6 months, and 1 year ]
    Register data



Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01841853


Locations
Sweden
Göteborgs Universitet, Institute of Neuroscience and Physiology, Section of Rehabilitation and Clinical Neuroscienses
Gothenburg, Sweden, 40530
Sponsors and Collaborators
Göteborg University
The Swedish Research Council
City of Gothenburg
Investigators
Study Director: Synneve Dahlin Ivanoff, Professor Göteborg University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Göteborg University
ClinicalTrials.gov Identifier: NCT01841853     History of Changes
Other Study ID Numbers: Livslots Angered
First Posted: April 29, 2013    Key Record Dates
Last Update Posted: September 27, 2016
Last Verified: September 2016

Keywords provided by Göteborg University:
Elderly
Health promotion
Randomized controlled study
Immigrant
Vulnerable population
ADL
KASAM
Implementation