|- candidate number||14839|
|- NTR Number||NTR3980|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||2-mei-2013|
|- Secondary IDs||12-096 METC UMC Utrecht|
|- Public Title||KWIEK. Investigating the effectiveness on self-management and quality of life of an integrated multidimensional lifestyle program in older adults. |
|- Scientific Title||KWIEK. A randomised controlled trial investigating the effectiveness of an integrated multidimensional lifestyle program on frailty, self-management and quality of life in older adults aged 65 and over living independently in the rural community of Wijk bij Duurstede.|
|- hypothesis||We will investigate the effect of the separate components of the KWIEK program on medication-use, physical fitness, mental health and nutritional status in a group frail, living independently, older adults (65 years or older).
Finally, the effect of KWIEK on primary care consumption will be evaluated.
|- Healt Condition(s) or Problem(s) studied||Frailty, Lifestyle intervention, Selfmanagement|
|- Inclusion criteria||1. A score of ≥ 1 on the Groningen Frailty Indicator (GFI);|
2. Age 65 and over;
3. ₋Inhabitant of the community of Wijk bij Duurstede;
4. Living independently, in an assistant living apartment near the local nursing home or in the habitat WOZOCO or visitor of the Uitwijk.
|- Exclusion criteria||1. Cognitively impaired (MMSE< 23 ; assessed at inclusion; pre-diagnostic interview);|
2.₋Severe immobility such as wheelchair dependent;
3.₋Inability to communicate in Dutch.
|- mec approval received||yes|
|- multicenter trial||no|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-aug-2012|
|- planned closingdate||1-aug-2014|
|- Target number of participants||400|
|- Interventions||The KWIEK-intervention is a structured and integrated intervention program that consists of the following four components:|
1. Medication improvement;
2. Improving physical fitness;
3. Improving social skills;
4. Improving nourishment.
Component 1) for medication improvement the POM-method (Prescribing Optimization Method) will be used.
Component 2) of the program focuses on physical fitness and aims to improve muscle strength, walking speed, fatigue through exercise. In this program daily activities which are considered the most problematic by the individual are trained. Walking stairs, shopping, moving outdoors, up from a chair or a bed etc. During these exercises the interplay of cognitive, perceptual, and motor functions and its closely linking to the individualĄŻs dynamic environment is trained.
Component 3) Social skills; especially for KWIEK an assertively training was developed. The main focus of this training is improving self-confidence and self-management enhancement; ask for support and sharing thoughts, saying no, making plans for the future. In this training the ACTOR-method is used . In this method an exercise program and social skills program are integrated.
Component 4) Improving the nutritional status; a nutrition education program is offered. The aim of this intervention is to increase the awareness about healthy diet and to increase self-care in nourishment. The final goal of this education program is to promote and maintain a healthy nutritional status and to optimize weight.
The control group is a wait list control group. After completion of the intervention period, the control group members have the priority to start with the KWIEK program.
|- Primary outcome||Primary endpoint for the effectiveness of the KWIEK intervention-part is the change in disability or limitations in daily living (GARS).|
|- Secondary outcome||1. Change in functional status (KATZ);|
2. Change in quality of life (SF-12);
3. Change in self management abilities (SMAS-30);
4. Health care consumption (additional questions; see Attachment F1.2);
5. Optimization of medication (POM);
6. Change in physical fitness (grip strength, 6 MWT,TUG, Demmi);
7. Change in mental health (HADS, de Jong-Gierveld Loneliness Scale);
8. Change in nutritional status (SNAQ65+, MUAC).
|- Timepoints||Every 20 weeks a new group of 10 participants starts the lifestyle program.
Every year (2011- 2013) in november, by means of a cohortstudy, the control group is assessed.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Dr. Bas Steunenberg|
|- CONTACT for SCIENTIFIC QUERIES||Dr. Bas Steunenberg|
|- Sponsor/Initiator ||University Medical Center Utrecht (UMCU), Julius Center for Health Sciences and Primary Care|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development, Municipality Wijk bij Duurstede|
|- Brief summary||Rationale: |
Frailty is a dynamic state affecting an individual who experiences losses in one or more domains of human functioning (physical, psychological or social), which is caused by the influence of a range of variables and which increases the risk of adverse outcomes, leading to the endpoint of frailty: functional disability. Frailty is assumed to be reversible and malleable by specific interventions that focus on risk factors. Knowledge about frailty offers care professionals at individual patient level a good opportunity for estimating future health risks and vulnerability in functionality of daily activities, social participation and self-management. Organizing demand-driven care tailor-made interventions with an important role for primary care, screening of frail groups and multidisciplinary cooperation are needed.
Objective: In the proposed study we aim to investigate determinants of frailty and the effectiveness of a of a structured multi-dimensional intervention program called ĄŽĄŻKWIEKĄŻĄŻ on frailty, self-care/functional abilities and quality of life, in different subgroups of frail older adults. Next to this we will investigate the effect of the separate components of the KWIEK program on medication-use, physical fitness, mental health and nutritional status?
Finally, the effect of KWIEK on primary care consumption will be evaluated.
Study design: In November 2011 a longitudinal cohort study in the community of Wijk bij Duurstede started to describe prevalence and incidence of frailty. Within this cohort a nested randomized controlled trial will be started (May 2012) to answer the research questions on the effectiveness of the KWIEK Program on the course and level of frailty and in preventing the onset of frailty.
Older adults (65 years or older) living independently in the community of Wijk bij Duurstede. Within this cohort study (n = 1066) a group of in total 400 older adults (score of 1 or higher on the GFI) will be recruited for the nested randomised controlled trial. Criteria for exclusion: Cognitively impaired (MMSE< 23 (0-30); Severe immobility or a language barrier.
KWIEK is a group-based program. Mean group size is 8 ¨C 10 older adults. The KWIEK-program consists of four components; monitoring medication by means of Prescribing Optimization Method, a physical training program, an assertiveness program to develop social skills, a nutritional education program.
Main study parameters/endpoints:
Primary outcome of the study is disability (measured by Groningen Activity Restriction Scale (GARS). Secundaire outcome measures are Quality of Life measured by means theShort-Form 12 (SF-12) and self-management in daily living by means of the KATZ-ADL and the Self Management Ability Scale (SMAS-30).
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
The risks associated with participation are minimized. The physical training program of daily activities is adapted to the target group. Other interventions concern welfare or information and prevention and our estimates are free of risks. Baseline measurement, measurements in between and follow up will take one hour. The length of the KWIEK-program is nearly 22 weeks (including holidays).
|- Main changes (audit trail)|
|- RECORD||2-mei-2013 - 20-mei-2013|