The reduction of disability in community-dwelling frail elderly

ISRCTN	ISRCTN31954692
DOI	https://doi.org/10.1186/ISRCTN31954692
Protocol serial number	ZonMw 60-61900-98-213
Sponsor	The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
Funder	The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)

Submission date: 19/10/2009
Registration date: 30/11/2009
Last edited: 09/01/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Gertrudis Kempen
Scientific

Universiteitssingel 40
Maastricht
6229 ER
Netherlands

Phone	+31 (0)43 388 2289
Email	g.kempen@zw.unimaas.nl

Study information

Primary study design	Interventional
Study design	Two-armed randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	The reduction of disability in community-dwelling frail elderly: a randomised controlled trial
Study objectives	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(s)	Medical Ethical Committee of Maastricht University/Academic Hospital Maastricht approval pending as of 20/10/2009 (ref: MEC 09-3-067)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	30/06/2012

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	All
Target sample size at registration	420
Key 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
Key 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
Date of first enrolment	04/11/2009
Date of final enrolment	30/06/2012

Locations

Countries of recruitment

Netherlands

Study participating centre

Universiteitssingel 40

Maastricht
6229 ER
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	10/09/2013		Yes	No
Results article	cost-effectiveness results	01/05/2015		Yes	No
Protocol article	protocol	23/08/2010		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes