Ignite Creation Date:
2024-05-06 @ 11:15 AM
Last Modification Date:
2024-10-26 @ 12:42 PM
Study NCT ID:
NCT03475576
Status:
COMPLETED
Last Update Posted:
2020-01-29
First Post:
2018-03-09
Brief Title:
Together in Line the Power of Informal Care in Group
Sponsor:
KU Leuven
Organization:
KU Leuven
Study Overview
Official Title:
Together in Line the Power of Informal Care in Group
Status:
COMPLETED
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
An aging population means an increase of the oldest part of the population resulting from a change in demographic behavior and an increasing lifespan The social networks are changing and the health care costs are rising We know informal care of older civilians becomes more and more complex A formal framework with a good communication to support informal caregivers is therefore essential in order to provide good care for a dependent older civilian
Informal care is the support and assistance of a dependent person outside the context of professional care or organized volunteering but by one or more members from the immediate vicinity of the dependent1 The informal care group is defined as follows a group of two or more persons who together provide informal care to a dependent person beyond the scope of professional care or organized volunteering but as members of the immediate vicinity of the dependent
In this group the different members contribute to the care process in an equitable but non-proportional manner The dynamics in an informal care group are obviously different from those in a family where one central informal caregiver is responsible for the care of the ill relative behind each individual of the informal care group there is also a partner andor children who influence the care motivations and accountability
Sharing informal caregiving has important advantages Firstly individuals of the informal care group needs less time to fulfill specific caregiver tasks and have more time to cope with external stressors Secondly caregivers in group receive support from each other which strengthens their self-efficacy However the involvement of more caregivers may also be a source of conflict
This project aims to meet the needs of informal care groups of older civilians An adjusted support for older civilians 70 years and their informal care group will be achieved We will focus on their needs aimed to decrease the caregiver burden and increase the well-being of both older civilian and caregivers This goal will be achieved by a better care planning and attempts to improve communication between older civilian informal and professional caregivers which we found in previous research as difficult and an important obstacle in concretize individual tailored support of the older civilian and caregivers
Informal care is the support and assistance of a dependent person outside the context of professional care or organized volunteering but by one or more members from the immediate vicinity of the dependent1 The informal care group is defined as follows a group of two or more persons who together provide informal care to a dependent person beyond the scope of professional care or organized volunteering but as members of the immediate vicinity of the dependent
In this group the different members contribute to the care process in an equitable but non-proportional manner The dynamics in an informal care group are obviously different from those in a family where one central informal caregiver is responsible for the care of the ill relative behind each individual of the informal care group there is also a partner andor children who influence the care motivations and accountability
Sharing informal caregiving has important advantages Firstly individuals of the informal care group needs less time to fulfill specific caregiver tasks and have more time to cope with external stressors Secondly caregivers in group receive support from each other which strengthens their self-efficacy However the involvement of more caregivers may also be a source of conflict
This project aims to meet the needs of informal care groups of older civilians An adjusted support for older civilians 70 years and their informal care group will be achieved We will focus on their needs aimed to decrease the caregiver burden and increase the well-being of both older civilian and caregivers This goal will be achieved by a better care planning and attempts to improve communication between older civilian informal and professional caregivers which we found in previous research as difficult and an important obstacle in concretize individual tailored support of the older civilian and caregivers
Detailed Description:
1 Study design The study has a before-and-after study design the tailored support will be available for every informal care group and no older civilian will be excluded from an optimal care context which is required by the social framework of this project Therefore no control group will be included in this study The intervention consists of already existing support although it is strengthened by means of a self-management tool the Keuzewijzer which helps the informal care group making specific choices with regard to tailored support adjusted to their needs norms and values By a pre- and post-test the effect of the intervention on the psychosocial well-being of the informal caregivers can be mapped out
2 Study population 21 Study population definition In this study informal care groups of older civilians will be included These civilians will be 70 years or older and have to live independently at home in the Leuven region The informal care groups consist of two or more relatives friends or neighbors caring for the older civilian 70 years beyond the scope of professional care or organized volunteering There are no age restriction for the informal caregivers
22 Inclusion and exclusion criteria Both the older civilians and the informal caregiver give their written consent after being informed Only civilians aged 70 years or older and their informal caregivers who have a thorough command of Dutch will be included Older civilians with a formal diagnosis of dementia too ill to participate or in a palliative phase be excluded
3 Intervention The intervention offered to the older civilians and their informal care groups will consist of an updated version of the Keuzewijzer which has been developed in an earlier phase of the research project This is a self-management tool which stimulates the communication within the informal care groups to make behaved choices concerning the care for the older civilian taking into account the standards values concerns and needs of every informal caregiver and older civilian
The following aspects will be discussed in the context of the care for the older civilian 1 analyzing the problem 2 detection of possibilities or alternatives 3 clarifying of motives and feelings and 4 weighting between values The first purpose of this intervention is to develop a care planning focused on the older civilians with a clear distribution of tasks The second purpose is to stimulate the communication between the informal caregivers and the older civilian allowing timely adjustments in the care planning and preventing for caregiver burden
The intervention consist of the following parts 1 introduction conversation 2 Keuzewijzer and 3 follow-up conversation In addition an evaluation of the intervention takes place at the end of the intervention study 6 months
31 Introduction conversation During this conversation a researcher will explain the dual purpose of the study in which on the one hand the psychosocial well-being of the informal caregivers and the older civilian is mapped by means of the personal interviews and on the other hand tailored support is offered through the intervention
The aim of this conversation consists of two aspects 1 providing information about the study and the informed consent and 2 making the informal care group sensitive to its own care context and the concerns and needs that exist
32 Intervention The intervention consists as explained earlier of a self-management tool based on the Keuzewijzer Both the individual members of the informal care group and the older civilian must complete this online tool individually preferably shortly after the introduction conversation After completing the Keuzewijzer the participants gets an overview of advice and referrals Hereby the informal care group gains insight into which existing support is available in response to their needs concerns values and standards Direct contact can be made with the organizations involved and the tailored support can be started
The aim of the intervention is to strengthen existing support for informal caregivers and to tailor this support on the needs and concerns of the informal care groups
33 Finishing conversation and evaluation of the intervention After the intervention the informal care group is offered a final conversation 6 months in which the effect of the intervention will be discussed and the intervention itself will be evaluated In addition this conversation offers the opportunity to discuss and refer to any outstanding needs and concerns A project employee will also guide this conversation
Together with the finishing conversation the informal caregivers and the older civilian are given the opportunity to evaluate the intervention by means of a focus group
The aim of this conversation is to consider together with the informal care group 1 the effect of the intervention 2 the possible concerns and needs to refer if necessary and 3 the intervention itself
4 Data collection The study will take place over the period of 6 months with two measurement moments within one month after including baseline and 6 months after inclusion The informal care groups and the older civilians will be questioned individually through a web survey about their general everyday functioning and physical and psychosocial well-being In addition current support apart from the study related support focused on the older civilian or caregiver needs will be accurately recorded This will allow to evaluate whether this contaminates the effect of the study intervention When a caregiver or older civilian is unable to complete the questionnaire online a paper version will be offered
41 Baseline data collection
At the first measurement moment baseline data will be collected through online questionnaires The questionnaires of both older civilian and caregiver will consist of the following parts
411 Informal caregiver
Background functional status and caregiving The information about the background and functional status of the informal caregiver will comprise 1 socio-demographic information eg age living conditions education and ethnicity and 2 physical well-being like subjective health evaluation visits to the GP and use of prescribed and OTC medication The information about caregiving will comprise 1 type of caregiving tasks 2 time investment 3 social and financial consequences of caregiving and 4 caregiving in group eg division of tasks communication group cohesion and dynamics
Psychosocial well-being
Regarding the psychosocial well-being of the caregivers of the informal care group the structured interviews will consist of the following questionnaires
Zarit Burden Inventory The Zarit burden interview ZBI a self-report scale is believed to be the most commonly used measure of caregiver burden Bachner et al showed that the ZBI was reliable across populations of caregivers and patients
Geriatric Depression Scale The most commonly used scale for late-life depression is the geriatric depression scale GDS The 15-item GDS has been shown to have adequate sensitivity and specificity and to be significantly more accurate than the 30-item GDS
State Trait Anxiety Inventory This subscale evaluates relatively stable aspects of anxiety including general states of calmness confidence and security In this study the Dutch version of the STAI will be used The Zelf-Beoordelings Vragenlijst STAI-DY
Spiritual resources needs The spiritual resources and needs of the individuals of the informal care group and the older civilian will be questioned through open questions
Support In this part of the structured interview informal caregiver will be asked about the current formal and informal support and their knowledge about available support and information channels The informal caregiver will also be asked about their role and experiences in the informal care group
412 Older civilians
Functioning The information about the functioning of the older civilians will comprise 1 socio-demographic information like age living conditions education and ethnicity 2 disease and treatment characteristics 3 activities of daily living ADL Barthel index and 4 instrumental activities of daily living IADL Lawton scale
Psychosocial well-being Regarding the psychosocial well-being of the older civilians the structured interviews will consist of the same questionnaires as for the informal caregivers except the Zarit Burden Inventory Besides the loneliness of the older civilian will be measured Loneliness is the subjective experience of social isolation and is associated with the well-being of community-dwelling older persons Loneliness has been less well studied and may be less definable than depression or social support But loneliness should certainly not be neglected as it has been shown that it is associated with adverse health consequences of older civilians In the Netherlands the loneliness scale of De Jong Gierveld and Kamphuis is generally used As this scale has been developed in Dutch has been used among older persons and has been proven to be a reliable and valid instrument that is robust to different data collecting modalities this scale will be used
Support In this part of the structured interview the older civilian will be asked like the informal caregiver about the current informal support and their knowledge about available support and information
42 Data collection during follow-up The data collection during follow-up will also take place online through a web survey The Zarit Burden Inventory ZBI-12 items and the Geriatric Depression Scale GDS-15 items will be included in the follow-up interview of the informal caregiver examine changes in their psychosocial well-being over time Besides the follow-up interviews also include questions about their physical well-being support functioning of the informal care group and socio-demographics The spiritual well-being coping and state anxiety of the informal caregiver are considered to remain stable over 6 months so these items will not be questioned again The follow-up interview of the older civilian will include the Geriatric Depression Scale GDS-15 items Activities of Daily Living ADL Barthel index and the Instrumental Activities of Daily Living IADL Lawton IADL scale besides socio-demographic questions
5 Statistical analysis Standard statistical analyses will be used for describing the characteristics of the older civilian and informal care group at baseline and during follow-up
When applicable more complex statistical methods will be used For example odds ratios and 95 confidence intervals for the different outcome parameters eg functional status physical and psycho-social well-being will be estimated using multivariable logistic regression models
2 Study population 21 Study population definition In this study informal care groups of older civilians will be included These civilians will be 70 years or older and have to live independently at home in the Leuven region The informal care groups consist of two or more relatives friends or neighbors caring for the older civilian 70 years beyond the scope of professional care or organized volunteering There are no age restriction for the informal caregivers
22 Inclusion and exclusion criteria Both the older civilians and the informal caregiver give their written consent after being informed Only civilians aged 70 years or older and their informal caregivers who have a thorough command of Dutch will be included Older civilians with a formal diagnosis of dementia too ill to participate or in a palliative phase be excluded
3 Intervention The intervention offered to the older civilians and their informal care groups will consist of an updated version of the Keuzewijzer which has been developed in an earlier phase of the research project This is a self-management tool which stimulates the communication within the informal care groups to make behaved choices concerning the care for the older civilian taking into account the standards values concerns and needs of every informal caregiver and older civilian
The following aspects will be discussed in the context of the care for the older civilian 1 analyzing the problem 2 detection of possibilities or alternatives 3 clarifying of motives and feelings and 4 weighting between values The first purpose of this intervention is to develop a care planning focused on the older civilians with a clear distribution of tasks The second purpose is to stimulate the communication between the informal caregivers and the older civilian allowing timely adjustments in the care planning and preventing for caregiver burden
The intervention consist of the following parts 1 introduction conversation 2 Keuzewijzer and 3 follow-up conversation In addition an evaluation of the intervention takes place at the end of the intervention study 6 months
31 Introduction conversation During this conversation a researcher will explain the dual purpose of the study in which on the one hand the psychosocial well-being of the informal caregivers and the older civilian is mapped by means of the personal interviews and on the other hand tailored support is offered through the intervention
The aim of this conversation consists of two aspects 1 providing information about the study and the informed consent and 2 making the informal care group sensitive to its own care context and the concerns and needs that exist
32 Intervention The intervention consists as explained earlier of a self-management tool based on the Keuzewijzer Both the individual members of the informal care group and the older civilian must complete this online tool individually preferably shortly after the introduction conversation After completing the Keuzewijzer the participants gets an overview of advice and referrals Hereby the informal care group gains insight into which existing support is available in response to their needs concerns values and standards Direct contact can be made with the organizations involved and the tailored support can be started
The aim of the intervention is to strengthen existing support for informal caregivers and to tailor this support on the needs and concerns of the informal care groups
33 Finishing conversation and evaluation of the intervention After the intervention the informal care group is offered a final conversation 6 months in which the effect of the intervention will be discussed and the intervention itself will be evaluated In addition this conversation offers the opportunity to discuss and refer to any outstanding needs and concerns A project employee will also guide this conversation
Together with the finishing conversation the informal caregivers and the older civilian are given the opportunity to evaluate the intervention by means of a focus group
The aim of this conversation is to consider together with the informal care group 1 the effect of the intervention 2 the possible concerns and needs to refer if necessary and 3 the intervention itself
4 Data collection The study will take place over the period of 6 months with two measurement moments within one month after including baseline and 6 months after inclusion The informal care groups and the older civilians will be questioned individually through a web survey about their general everyday functioning and physical and psychosocial well-being In addition current support apart from the study related support focused on the older civilian or caregiver needs will be accurately recorded This will allow to evaluate whether this contaminates the effect of the study intervention When a caregiver or older civilian is unable to complete the questionnaire online a paper version will be offered
41 Baseline data collection
At the first measurement moment baseline data will be collected through online questionnaires The questionnaires of both older civilian and caregiver will consist of the following parts
411 Informal caregiver
Background functional status and caregiving The information about the background and functional status of the informal caregiver will comprise 1 socio-demographic information eg age living conditions education and ethnicity and 2 physical well-being like subjective health evaluation visits to the GP and use of prescribed and OTC medication The information about caregiving will comprise 1 type of caregiving tasks 2 time investment 3 social and financial consequences of caregiving and 4 caregiving in group eg division of tasks communication group cohesion and dynamics
Psychosocial well-being
Regarding the psychosocial well-being of the caregivers of the informal care group the structured interviews will consist of the following questionnaires
Zarit Burden Inventory The Zarit burden interview ZBI a self-report scale is believed to be the most commonly used measure of caregiver burden Bachner et al showed that the ZBI was reliable across populations of caregivers and patients
Geriatric Depression Scale The most commonly used scale for late-life depression is the geriatric depression scale GDS The 15-item GDS has been shown to have adequate sensitivity and specificity and to be significantly more accurate than the 30-item GDS
State Trait Anxiety Inventory This subscale evaluates relatively stable aspects of anxiety including general states of calmness confidence and security In this study the Dutch version of the STAI will be used The Zelf-Beoordelings Vragenlijst STAI-DY
Spiritual resources needs The spiritual resources and needs of the individuals of the informal care group and the older civilian will be questioned through open questions
Support In this part of the structured interview informal caregiver will be asked about the current formal and informal support and their knowledge about available support and information channels The informal caregiver will also be asked about their role and experiences in the informal care group
412 Older civilians
Functioning The information about the functioning of the older civilians will comprise 1 socio-demographic information like age living conditions education and ethnicity 2 disease and treatment characteristics 3 activities of daily living ADL Barthel index and 4 instrumental activities of daily living IADL Lawton scale
Psychosocial well-being Regarding the psychosocial well-being of the older civilians the structured interviews will consist of the same questionnaires as for the informal caregivers except the Zarit Burden Inventory Besides the loneliness of the older civilian will be measured Loneliness is the subjective experience of social isolation and is associated with the well-being of community-dwelling older persons Loneliness has been less well studied and may be less definable than depression or social support But loneliness should certainly not be neglected as it has been shown that it is associated with adverse health consequences of older civilians In the Netherlands the loneliness scale of De Jong Gierveld and Kamphuis is generally used As this scale has been developed in Dutch has been used among older persons and has been proven to be a reliable and valid instrument that is robust to different data collecting modalities this scale will be used
Support In this part of the structured interview the older civilian will be asked like the informal caregiver about the current informal support and their knowledge about available support and information
42 Data collection during follow-up The data collection during follow-up will also take place online through a web survey The Zarit Burden Inventory ZBI-12 items and the Geriatric Depression Scale GDS-15 items will be included in the follow-up interview of the informal caregiver examine changes in their psychosocial well-being over time Besides the follow-up interviews also include questions about their physical well-being support functioning of the informal care group and socio-demographics The spiritual well-being coping and state anxiety of the informal caregiver are considered to remain stable over 6 months so these items will not be questioned again The follow-up interview of the older civilian will include the Geriatric Depression Scale GDS-15 items Activities of Daily Living ADL Barthel index and the Instrumental Activities of Daily Living IADL Lawton IADL scale besides socio-demographic questions
5 Statistical analysis Standard statistical analyses will be used for describing the characteristics of the older civilian and informal care group at baseline and during follow-up
When applicable more complex statistical methods will be used For example odds ratios and 95 confidence intervals for the different outcome parameters eg functional status physical and psycho-social well-being will be estimated using multivariable logistic regression models
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None