|- candidate number||28464|
|- NTR Number||NTR6964|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||20-jan-2018|
|- Secondary IDs||520002003 / 15/517 ZonMw / Medical Research Ethics Committee |
|- Public Title||The impact of Function Focused Care in Hospital (FFCiH) on geriatric and stroke patients.|
|- Scientific Title||Effectiveness, Costs and Feasibility of Function Focused Care in Hospital (FFCiH).|
|- hypothesis||The study hypothesis is that FFCiH will maintain or improve functional status and physical activity in hospitalized stroke and geriatric patients compared to usual care. |
|- Healt Condition(s) or Problem(s) studied||Physical activity, Activities of Daily Life (ADL), Geriatric patients, Stroke patients, Functional status, Hospitalization, Basic nursing care|
|- Inclusion criteria||- stroke (onset < 1 week) patients admitted to the neurological ward|
- geriatric patients admitted to the geriatric ward
|- Exclusion criteria||- a life-threatening situation or in a terminal phase on admission;|
- Dutch language barrier regardless of cognitive or communicative impairments;
- Already participated once in the FFCiH study
- Hospitalization duration of < 48 hours
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||5-feb-2016|
|- planned closingdate||5-mrt-2018|
|- Target number of participants||800|
|- Interventions||In the intervention group, trained nurses will stimulate patients in active engagement in daily activities instead of taking over those activities with the aim that patients maintain or restore their physical functioning. Examples of FFCiH include walking with the patient to the toilet instead of giving him a urinal in bed or using verbal cues during bathing. Key elements of the FFCiH approach are goal setting in collaboration with the patients and motivational techniques.|
Patients in the control group will receive care as usual
|- Primary outcome||1. Bathing & Dressing: measured by the Barthel-Index (BI) supplemented with the total number of body parts the patient washed and dressed himself.|
2. Mobility: measured by the Elderly Mobility Scale (EMS). In case of a maximum score of the EMS (patient performs all tasks without any problem), the EMS will be followed by the 2-minute walk test.
|- Secondary outcome||Measurements at patients|
1. Depression: measured by the Patient Health Questionnaire (PHQ) or by the Signs of Depression Scale-Revised (SODS-R) in case patients are not able to communicate due to aphasia or cognitive problems.
2. Health-related quality of life: measured by the EQ-5D-5L
3. Satisfaction with care: measured by one general question of the CQ-Index
4. Fear of falling: measured by the short Falls Efficacy Scale-International (Short FES-I)
5. Self-efficacy and Outcome expectations for Functional and Exercise activities: measured by Self-Efficacy and Outcome Expectations scales for Restorative Care.
6. Motivation: measured by the Apathy evaluation scale.
7. Resilience: measured by the Psychical Resilience Measure.
Measurements at nurses
1. Barriers and facilitators regarding implementation: measured by the Barriers and facilitators assessment instrument
2. Team learning: measured by the team learning scale for nursing teams
3. Knowledge of FFCiH: measured by the translated Nursing Assistants Theoretical Testing of Restorative Care Activities.
4. Self-efficacy and Outcome expectations with performing FFCiH-activities measured by the Assistant Self-efficacy (NASERC) and Outcome expectations (NAOERC) for Restorative Care Scale.
|- Timepoints||Timepoints Primary Outcomes (patients):|
baseline at hospital admission, day 7 after hospital admission, the day of discharge, 3 and 6 months after discharge.
Timepoints Secondary outcomes (patients):
baseline at hospital admission, day of discharge, 3 and 6 months after discharge
Timepoints Secondary outcomes (nurses)
baseline (before implementation of FFCiH), 3 and six months after implementation of FFCiH.
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||PhD RN Janneke de Man-van Ginkel|
|- CONTACT for SCIENTIFIC QUERIES||PhD RN Janneke de Man-van Ginkel|
|- Sponsor/Initiator ||University Medical Center Utrecht (UMCU)|
(Source(s) of Monetary or Material Support)
|- Brief summary||Normal aging, chronic and acute diseases such as a stroke cause functional decline whereby the person needs basic nursing care structurally or temporarily. Additionally, hospitalization itself often leads to deterioration in physical functioning in patients. Early activity, beginning as soon as possible after hospital admission, has been shown to benefit physical functioning in geriatric and stroke patients. However, the literature also shows that hospitalized adults are physically inactive and spend most of the time in bed. As a result, functional decline occurs. This is proven to be an important predictor for a prolonged length of hospital stay, loss of independence, high costs and increasing mortality. Considering the nature of their care, nurses can play an important role to prevent further disability and optimize the functional status of their patients. However, nurses tend to meet their patientsí needs by task completion rather than by stimulating active engagement in daily activities.|
Function Focused Care in Hospital (FFCiH) is an approach that stimulates nurses to encourage a patient to take a more active part in the activities of daily living and to increase patientsí time spent in physical activity to attain and maintain their highest level of function. FFC has been developed in nursing homes in the USA and evaluated in several care settings, especially in long-term settings in elderly patients. Although results of these studies provided support for the safety and efficacy of the FFC-approach in those settings, there is little research to evaluate the effectiveness of FFC in hospitalized patients.
The Medical Research Council has been used to adapt the FFC approach to the Dutch Hospital Setting. In phase I the FFC approach was translated and developed in collaboration with future users, eight nurses working in two different hospitals in the Netherlands. In phase II a pilot study was conducted to test the practicability of the data collection and the feasibility of the FFCiH. This pilot showed that FFCiH is adaptable to the Dutch hospital care and gave relevant information regarding challenges for implementation of this intervention.
A multicenter stepped wedge cluster trial is currently running comparing FFCiH with care as usual in 4 different wards (two neurological and two geriatric) of two hospitals in the Netherlands, in which approximately 800 hospitalized geriatric and stroke patients will participate. In the first four months, none of the wards will receive the intervention. Then, FFCiH will be implemented sequentially in all participating wards every four months. Nurses will be trained in delivering the intervention by two-hour training sessions and bed-side teaching. So, all wards will shift from care as usual (control period) to the intervention (intervention period). Outcomes will be compared within and across wards. During the 4 months implementation period (transition) no patient outcomes will be measured.
Alongside, a process evaluation will be conducted to facilitate interpretation of outcome effects and to gain insight into the experiences of nurses and patients with regard to benefits, burden, stimulating factors and barriers.
|- Main changes (audit trail)|
|- RECORD||20-jan-2018 - 28-jan-2018|