|- candidate number||9080|
|- NTR Number||NTR2737|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||7-feb-2011|
|- Secondary IDs||311070303 / 10-4-015; ZonMw / MEC azM/UM|
|- Public Title||The added value of [G]OLD: An evaluation study of the effects of screening elderly people in order to detect frailty at an early stage. (In Dutch: De waarde van [G]OUD: Een evaluatiestudie naar de effecten van de consultatiefunctie voor ouderen.)|
|- Scientific Title||The added value of [G]OLD: An evaluation study of the effects of screening elderly people in order to detect frailty at an early stage. (In Dutch: De waarde van [G]OUD: Een evaluatiestudie naar de effecten van de consultatiefunctie voor ouderen.)|
|- ACRONYM||[G]OLD, Getting OLD the healthy way (in Dutch: [G]OUD, Gezond OUD in Limburg)|
|- hypothesis||Due to the ageing of the population, the number of (frail) elderly people who suffer from (multi)complex health complaints increases and this ultimately threatens their ability to function independently. Preventive home visitation programmes may support older people to grow old at home. Recent studies emphasize the importance of embedding home visitation programmes into existing primary care systems and tailoring care to older peopleís needs and wishes. In this study we aim to investigate the effects and feasibility of the early detection of health problems among community-dwelling older people and their subsequent referral to appropriate care and/or well-being facilities by general practices. We hypothesize that a comprehensive multidimensional assessment of the health and well-being of people (75+) by general practices and subsequent individualized care and follow-up (if required) will lead to sustained or improved health-related quality of life and reduced disability. Furthermore, we believe that this approach will be valued by and will be feasible for both older people and caregivers. |
|- Healt Condition(s) or Problem(s) studied||Frailty, Health-related quality of life, Disability|
|- Inclusion criteria||1. Age 75 years and over, either sex;|
2. Informed consent.
|- Exclusion criteria||1. Not living independently;|
2. On a waiting list for admission to a nursing home or home for the elderly;
3. Under close medical supervision (chemotherapy, chronic haemodialysis or other therapies posing a high burden on the person);
4. Terminally ill.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||12-mei-2010|
|- planned closingdate||31-jan-2013|
|- Target number of participants||1716|
|- Interventions||In total, 14 general practices will participate in the intervention group and 13 general practices will participate in the control group. All participating general practices randomly select community-dwelling people aged 75 years and older from the GPís Information System.
Practice nurses from intervention practices:
1. Visit older people at home for a comprehensive assessment of their health and well-being. For this purpose they use the so-called [G]OLD-instrument: a structured, multidimensional instrument to assess the personís physical, psychological, mental and social functioning, as well as lifestyle and medication use;
2. Discuss results with the GP. The results of the [G]OLD-instrument, as well as the patientís needs and wishes, determine whether follow-up actions regarding certain problems are needed. These actions may consist of additional diagnosis, preventive care or advise, treatment in primary health care or referral to other care and/or well-being facilities as much as possible in the older personís neighbourhood;
3. Formulate Ė if required Ė a care and treatment plan together with the patient;
4. Refer patient to care and/or well-being facilities (if applicable);
5. Monitor and coordinate care and follow-up. The need for and frequency of follow-up contacts strongly depends on the type of problems or complaints that deserve attention according to the care and treatment plan.
Control practices provide usual care (access to the ordinary range of health care services available).
|- Primary outcome||The primary outcome measures are health-related quality of life, measured by the RAND-36, and disability, assessed using the Groningen Activity Restriction Scale (GARS).|
Sample size calculations are based on the RAND-36.
|- Secondary outcome||1. Attitude towards ageing (subscale attitude toward own ageing from the PGC Morale Scale);|
2. Health care utilization (number of contacts with different health care providers, e.a., GP consultations, hospital admission);
3. Admission to nursing home or home for the elderly (number of admissions and time to admission from T0 to T3);
4. Mortality (number of deaths from T0 to T3).
|- Timepoints||The outcome measures health-related quality of life, disability and attitude towards ageing are included in a postal questionnaire send to older people at baseline, 6-months, 12-months and 18-months follow-up.|
The additional secondary outcomes admission to a nursing home or home for the elderly, health care utilization, and mortality are continuously registered by general practices during the study period in the GPís Information System. Data are extracted for each patient after 18-months follow-up. Health care utilization is also recorded by the older people themselves during the study period (T0 to T3) in a care booklet specifically developed for [G]OLD.
|- Trial web site||http://www.goudlimburg.nl|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||Drs. Mandy Stijnen|
|- CONTACT for SCIENTIFIC QUERIES||Drs. Mandy Stijnen|
|- Sponsor/Initiator ||Maastricht University Medical Center (MUMC+)|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||A longitudinal, quasi-experimental study is performed in three regions in the south of the Netherlands. General practices in these regions were invited to participate in the evaluation study. Participating general practices randomly selected community-dwelling people aged 75 years and older from the GPís Information System. Older people within intervention practices are visited at home by the practice nurse for a multidimensional assessment followed by individualized care. Older people from control practices receive usual care. Primary outcome measures are health-related quality of life and disability. Effects on primary and secondary outcome measures are assessed at baseline (T0), 6-months (T1), 12-months (T2), and 18-months (T3) after baseline. Parallel to the effect study, a process evaluation will provide insight into the barriers and facilitators for implementing [G]OLD within general practices.|
|- Main changes (audit trail)|
|- RECORD||7-feb-2011 - 16-sep-2013|