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

May 9, 2019 updated by: Göteborg University

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

131

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Gothenburg, Sweden, 40530
        • Synneve Dahlin-Ivanoff

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Activities of Daily Life (ADL)
Time Frame: change from baseline at 6 months and 1 year
The ADL-staircase
change from baseline at 6 months and 1 year
Change of Sense of Coherence (KASAM)
Time Frame: change from basline at 6 months and 1 year
KASAM (by Antonovsky)
change from basline at 6 months and 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Fatigue
Time Frame: baseline, 6 months, and 1 year
The Mob-T scale
baseline, 6 months, and 1 year
Change of Grip strength
Time Frame: baseline, 6 months, and 1 year
North Coast-dynamometer
baseline, 6 months, and 1 year
Change of Physical activity
Time Frame: basline, 6 months, and 1 year
Questionnaire and Physical and domestic activity scale
basline, 6 months, and 1 year
Change of Balance
Time Frame: basline, 6 months, and 1 year
The balance scale
basline, 6 months, and 1 year
Change of Gait speed
Time Frame: basline, 6 months, and 1 year
Four-meter walking test
basline, 6 months, and 1 year
Change of Weight loss
Time Frame: basline, 6 months, and 1 year
The Göteborg Quality of Life Instrument
basline, 6 months, and 1 year
Change of Cognition
Time Frame: basline, 6 months, and 1 year
Mini Mental State Examination (MMSE)
basline, 6 months, and 1 year
Change of Visual impairment
Time Frame: basline, 6 months, and 1 year
KM-visual acuity chart
basline, 6 months, and 1 year
Change of Falls
Time Frame: basline, 6 months, and 1 year
Questionnaire
basline, 6 months, and 1 year
Change of Fear of falls
Time Frame: baseline, 6 months, 1 year
FES-I
baseline, 6 months, 1 year
Change of Illness
Time Frame: Baline, 6 months, and 1 year
CIRS-G
Baline, 6 months, and 1 year
Change of Symptoms
Time Frame: Basline, 6 months, and 1 year
The Göteborg Quality of Life Instrument
Basline, 6 months, and 1 year
Change of Change of Depression
Time Frame: Baseline, 6 months, and 1 year
GDS 20
Baseline, 6 months, and 1 year
Health-care consumption
Time Frame: Baseline, 6 months, and 1 year
Register data
Baseline, 6 months, and 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Synneve Dahlin-Ivanoff, Professor, Göteborg University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

April 10, 2013

First Submitted That Met QC Criteria

April 24, 2013

First Posted (Estimate)

April 29, 2013

Study Record Updates

Last Update Posted (Actual)

May 13, 2019

Last Update Submitted That Met QC Criteria

May 9, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

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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