Condition category
Not Applicable
Date applied
19/10/2009
Date assigned
30/11/2009
Last edited
09/01/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.zonmw.nl

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

  1. 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.

  2. 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.

  3. 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 .

Additional files

Editorial Notes