Contact information
Type
Scientific
Primary contact
Prof Gertrudis Kempen
ORCID ID
Contact details
Universiteitssingel 40
Maastricht
6229 ER
Netherlands
+31 (0)43 388 2289
g.kempen@zw.unimaas.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
ZonMw 60-61900-98-213
Study information
Scientific title
The reduction of disability in community-dwelling frail elderly: a randomised controlled trial
Acronym
Study hypothesis
1. What is the effectiveness of a tailor-made, multi-component intervention in reducing disability and several secondary functional outcomes in frail elderly?
2. What is the impact of the intervention on the central informal caregiver with respect to perceived burden on health-related quality of life?
3. What is the impact of the intervention on health care utilisation, consumed goods and related costs?
4. Is the intervention performed according to the protocol, is the target group compliant with the intervention, and how is the content of the program valued by the target group and facilitators?
Ethics approval
Medical Ethical Committee of Maastricht University/Academic Hospital Maastricht approval pending as of 20/10/2009 (ref: MEC 09-3-067)
Study design
Two-armed randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Disability prevention in frail elderly
Intervention
12 GP practices will be selected and randomly allocated to the intervention group or control group; data will be collected at 6, 12 and 24 months follow-up.
The focus of the intervention is on disability prevention. It is a tailor-made and multidisciplinary intervention that consists of six steps. After an initial postal screening (step 1) of frail older people (GFI score of 6 and higher) a comprehensive multidimensional assessment (step 2) is conducted by a practice nurse in collaboration with the general practitioner (GP). The assessment phase focuses on the identification of existing limitations in daily life and on risk factors for future limitations (e.g. polypharmacy, mobility, falls, lack of social and productive activities, cognitive impairments). Practice nurse and GP determine whether additional assessments are needed, e.g. by a physiotherapist. After the assessment(s), the practice nurse and GP formulate an interim action plan (step 3). In case of complex problems clients can be discussed in a multidisciplinary team (practice nurse, GP, physiotherapist and occupational therapist).
Consequently, a meeting between the practice nurse and the client (and informal caregiver, if possible) takes place to define a final action plan, including goals, strategies and actions (step 4). The action plan can be related to a toolbox of interventions, which will be executed by the multidisciplinary team (step 5). During executing and after finishing the components of the toolbox the practice nurse and the client evaluate the achievement of goals, the implementation of strategies into daily life and the need for support in the following period (step 6).
During all phases of the intervention the use of self-management abilities will be stimulated. Self-management means that people take responsibility for their own health and well-being. A feeling of competence to change behaviour and a feeling of control over specific situations are important concepts within self-management; both are needed to change behaviour. Self-management supports people in maintaining their daily activities and social roles. Frail elderly learn to cope with changes that are due to diseases or disability by means of their rest-capacities and environmental resources, which is essential for daily functioning and quality of life. Self-activation and self-motivation are important features during all sessions. Therefore motivational interviewing techniques, such as client-centred counselling style, reflective listening and asking directive questions, are added. Motivational interviewing is a directive counselling-style in interventions to change behaviour. It has shown to be effective in both in-home and telephone-based interventions.
Older people in the control group are also identified as frail by means of the screening list (GFI score of 6 or higher). They receive care as usual; they can use and apply for all services as before.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
The Groningen Activity and Restriction Scale (GARS) measures disability. The GARS will be assessed in a telephone interview at baseline and at 6, 12, and 24 months follow-up.
Secondary outcome measures
The following secondary outcomes will be assessed in a telephone interview at baseline, and at 6, 12, and 24 months follow-up:
1. Depression (Hospital Anxiety and Depression Scale)
2. Cognitive status (Telephone Interview Cognitive Status)
3. Fear of falling (Shorted Falls Efficacy Scale-International)
4. Participation (Maastricht Social Participation Profile, scale A)
5. Frequency of falls, assessed by the question: "How often do you have fallen during the past 6 months?"
6. Mortality, health care utilisation/consumed goods and related costs are registered during 24 months. The use of health care services relates to the frequency and duration of care from the following services: community health and social services, primary health care services and institutional care. Consumed goods are: helping aids, assistive devices and medication use.
As the proposed study will be embedded in the NPO, the MDS (Minimal Data Set) will be applied at baseline, 6, 12, and 24 months follow up by means of a postal questionnaire. The MDS provides global data on: age, gender, marital status, ethnicity, living arrangements, socio-economic status, level of education, health perception, multi-morbidity, daily functioning in ADL, mental well-being, cognitive functioning, social functioning and quality of life. Data about the impact of the intervention on informal caregivers (perceived burden and health-related quality of life) will also be provided by the MDS.
Questions about social support interactions (Social Support List - Interaction version) and a question about feelings of loneliness (During the past 4 weeks, how often did you feel lonely?) are added.
Overall trial start date
04/11/2009
Overall trial end date
30/06/2012
Reason abandoned
Eligibility
Participant inclusion criteria
1. Frailty: score of 6 or higher on Groningen Frailty Scale (GFI)
2. Community-dwelling
3. Aged 70 years and over, either sex
4. Willingness to participate
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
420 participants
Participant exclusion criteria
1. Those on a waiting list for admission to a nursing home
2. Cognitive impairments (Telephone Interview for Cognitive Status [TICS] less than 16)
3. Unable to communicate in Dutch
4. Confined to bed
Recruitment start date
04/11/2009
Recruitment end date
30/06/2012
Locations
Countries of recruitment
Netherlands
Trial participating centre
Universiteitssingel 40
Maastricht
6229 ER
Netherlands
Sponsor information
Organisation
The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
Sponsor details
Laan van Nieuw Oost Indie 334
The Hague
2593 CE
Netherlands
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2010 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/20731836
2. 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24022033
3. 2015 cost-effectiveness results in: http://www.ncbi.nlm.nih.gov/pubmed/25566783
Publication citations
-
Protocol
Metzelthin SF, van Rossum E, de Witte LP, Hendriks MR, Kempen GI, The reduction of disability in community-dwelling frail older people: design of a two-arm cluster randomized controlled trial., BMC Public Health, 2010, 10, 511, doi: 10.1186/1471-2458-10-511.
-
Results
Metzelthin SF, van Rossum E, de Witte LP, Ambergen AW, Hobma SO, Sipers W, Kempen GI, Effectiveness of interdisciplinary primary care approach to reduce disability in community dwelling frail older people: cluster randomised controlled trial., BMJ, 2013, 347, f5264.
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Results
Metzelthin SF, van Rossum E, Hendriks MR, De Witte LP, Hobma SO, Sipers W, Kempen GI, Reducing disability in community-dwelling frail older people: cost-effectiveness study alongside a cluster randomised controlled trial, Age Ageing, 2015 .