The cost-effectiveness of systematic home visits by nurses of frail elderly primary care patients and caregivers of demented patients
| ISRCTN | ISRCTN05358495 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN05358495 |
| Secondary identifying numbers | N/A |
- Submission date
- 09/08/2004
- Registration date
- 25/01/2005
- Last edited
- 15/08/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Hein van Hout
Scientific
Scientific
VU University Medical Centre
EMGO-Institute
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
| Phone | +31 (0)20 4448199 |
|---|---|
| Hpj.vanhout@vumc.nl |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Quality of life |
| Scientific title | The cost-effectiveness of systematic home visits by nurses of frail elderly primary care patients and caregivers of demented patients |
| Study acronym | PIKO - Preventieve Interventie bij Kwetsbare Ouderen (Preventive Intervention for Frail Older persons) |
| Study objectives | 1. To evaluate the cost-effectiveness of systematic home visits by nurses to frail elderly primary care patients. |
| Ethics approval(s) | The Ethical Committee of the VU medical center approved the study. |
| Health condition(s) or problem(s) studied | Frailty, Dementia |
| Intervention | Trained community nurses visit patients at home, assess the care needs with the Resident Assessment Instrument - Home Care (RAI-HC), a multidimensional geriatric assessment. Computerisation enables direct identification of problem areas. The nurses make and execute standardised care-plans, targeted at individual needs that comply with patient priorities. The nurses visit the patients at least five times during a year in order to execute and monitor the care-plan. Special attention is paid to caregivers of demented persons by family meetings. Controls receive usual care. |
| Intervention type | Other |
| Primary outcome measure | Health related quality of life as measured with the Short Form 36 (SF-36), and Quality Adjusted Life Years by health utilities based on Euroqol (EQ-5D), measured at baseline, 6 and 18 months. |
| Secondary outcome measures | 1. (Days until) institutionalization: hospital stay, placement in nursing home or home for the elderly are surveyed and crosschecked at institutes, measured at baseline, 6 and 18 months 2. Hospital admissions, measured at 18 months 3. (Days until) mortality as checked with the Primary Care Physicians (PCPs), measured at 18 months 4. Direct costs as measured by patient questionnaires with three-monthly recall periods. These self-report data are supplemented by data from the centralized regional pharmacy database (medication use), regional hospital check, and nursing home checks. In case patients are not able to fill out the forms themselves a close relative will be approached, measured at baseline, 6 and 18 months |
| Overall study start date | 01/07/2002 |
| Completion date | 30/04/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 1100 |
| Key inclusion criteria | 1. Frail elderly as defined by: 1.1. Aged 75+ years persons living at home who score in the worst quartile of at least two of six COOP-charts are considered frail 1.2. Persons at high risk on the 7-minute screen and below the threshold of the Mini-Mental State Examination (MMSE) (less than 24) 2. Caregivers of demented persons (under 1.2.) |
| Key exclusion criteria | Does not comply with the above inclusion criteria |
| Date of first enrolment | 01/07/2002 |
| Date of final enrolment | 30/04/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
VU University Medical Centre
Amsterdam
1081 BT
Netherlands
1081 BT
Netherlands
Sponsor information
Vrije University Medical Centre (VUMC) (Netherlands)
Hospital/treatment centre
Hospital/treatment centre
EMGO Institute
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
| Website | http://www.vumc.nl/ |
|---|---|
"ROR" |
https://ror.org/00q6h8f30 |
Funders
Funder type
Research organisation
Vrije University Medical Centre (VUMC) (Netherlands) (ref: 2002/121)
No information available
The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands) (ref: 2200-114)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | design and pilot results | 08/09/2005 | Yes | No | |
| Results article | results | 01/07/2010 | Yes | No | |
| Other publications | Correction to results article | 14/08/2024 | 15/08/2024 | Yes | No |
Editorial Notes
15/08/2024: Publication reference added.
