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The reduction of disability in community-dwelling frail elderly

The reduction of disability in community-dwelling frail elderly: a randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN31954692
Enrollment
420
Registered
2009-11-30
Start date
2009-11-04
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disability prevention in frail elderly Not Applicable

Interventions

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.

Sponsors

The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 31, 2026