Ignite Creation Date:
2024-05-06 @ 5:00 PM
Last Modification Date:
2024-10-26 @ 2:20 PM
Study NCT ID:
NCT05156346
Status:
COMPLETED
Last Update Posted:
2023-05-18
First Post:
2021-11-12
Brief Title:
Pragmatic RCT to Assess the Effectiveness of an Online Self-help Programme for Older Adults After Spousal Bereavement
Sponsor:
Universidade Nova de Lisboa
Organization:
Universidade Nova de Lisboa
Study Overview
Official Title:
Study Protocol for a 10-week Pragmatic Two-arm Randomised Controlled Trial to Assess the Effectiveness of LEAVES an Internet-based Self-help Programme for Older Adults After Spousal Bereavement
Status:
COMPLETED
Status Verified Date:
2023-05
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:
LEAVES-PT
Brief Summary:
Introduction The death of a partner is a frequent and very stressful critical life event in later life Grief and psychological distress after the loss of a partner are normative reactions However 10 of individuals are less able to cope with bereavement and show symptoms of disturbed or prolonged grief or adaptation problems Focus groups have concluded that Portuguese older adults who lost their partner avoid and downplay the grief process not seeking help when needed LEAVES is an interactive self-help online programme founded in the task model of mourning and the dual-process model of coping with bereavement that supports older adults who have lost their partner in dealing with and preventing prolonged grief As part of an international consortium with two more trial centres LEAVES-PT will carry out a 10-week pragmatic randomised two-armed parallel-group controlled trial to determine the effectiveness of LEAVES vs usual care in reducing grief in community-dwelling Portuguese adults over 55 years who have lost a partner Besides the clinical evaluation a cost-effectiveness analysis will be carried out
Methods Adults over 55 years who have lost a partner and are registered with a primary care service in Lower Alentejo Portugal will be invited to participate and after screening for eligibility a minimum of 100 will be randomised to one of two arms usual care LEAVES online service or usual care 11 The intervention will last for 10 weeks and follow-up will last for a further 10 weeks 20 weeks Grief is the primary endpoint and it is measured by the Texas Revised Inventory of Grief Linear mixed models will be used to determine the effectiveness of LEAVES on grief symptoms using the intention-to-treat principle Due to several recruitment barriers the study ultimately became a pre-post study with only 1 intervention arm
Methods Adults over 55 years who have lost a partner and are registered with a primary care service in Lower Alentejo Portugal will be invited to participate and after screening for eligibility a minimum of 100 will be randomised to one of two arms usual care LEAVES online service or usual care 11 The intervention will last for 10 weeks and follow-up will last for a further 10 weeks 20 weeks Grief is the primary endpoint and it is measured by the Texas Revised Inventory of Grief Linear mixed models will be used to determine the effectiveness of LEAVES on grief symptoms using the intention-to-treat principle Due to several recruitment barriers the study ultimately became a pre-post study with only 1 intervention arm
Detailed Description:
Introduction
Theoretical background
The death of a partner is a frequent and very stressful critical life event in later life It implies a dissolution of social and emotional ties This deeply affects the attachment system requires the acceptance of the loss as well as the formation of a new identity and a new perspective for the future It involves the adaptation of daily routines which can be even more challenging when social physical and financial resources decline in later life Grief and psychological distress after the loss of a partner are normative reactions For most people grief intensity weakens to a manageable degree within several weeks or months After the most intensive period grief is still present but the loss becomes gradually integrated and no longer hinders the way of ongoing life However some individuals are less able to cope with bereavement and show symptoms of disturbed or prolonged grief or adaptation problems About 10 of older adults develop a prolonged grief disorder or persistent complex bereavement disorder characterised by separation distress frequent or disabling cognitive emotional and behavioural symptoms such as avoidance of reminders of the loved one difficulties moving on with life and functional impairment The development of prolonged grief or adaptation problems often goes unnoticed by the widower who then fail to realize that help may be needed This leads to a situation in which older adults are unaware of their own needs do not seek help and do not receive the care needed Previous focus groups and stakeholders feedback have noted that Portuguese older adults who lost their partner and their family members avoid and downplay the grief process not seeking help when needed This may lead to a high usage of primary care and later on to mental health services with complaints of insomnia physical and depressive symptoms
A wide range of interventions are available for either preventing or treating prolonged grief disorder including support groups writing exercises and individual psychological counselling and more recently internet-based options Such interventions mostly consist of writing exercises with minimal therapist involvement Previously Brodbeck and colleagues found that a 12-week intervention with a bereavement online support service LIVIA in Swiss adults 40 years old had a medium to large effect on grief depression and loneliness over 3 months as well as increasing life satisfaction
Adapted from LIVIA and combining features from the Before you leave app LEAVES is an online self-help interactive programme founded in the task model of mourning and the dual-process model of coping with bereavement that supports older adults who have lost their partner in dealing with and preventing prolonged grief following a user-centred iterative and agile approach In LEAVES-PT the investigators will carry out a 10-week pragmatic randomised two-armed parallel-group controlled trial to compare the effectiveness of LEAVES vs usual care in reducing grief in community-dwelling Portuguese adults over 55 years registered with the local primary care unit Besides the clinical evaluation a qualitative study of implementation and engagement with the LEAVES online service and a cost-effectiveness analysis will be carried out This trial LEAVES-PT is part of a larger study from an international consortium LEAVES with two more trial centres but with distinct design and methodology The Netherlands and Switzerland
Context on Lower Alentejos Population and ULSBA
LEAVES-PT is coordinated by the Local Health Unit of Lower Alentejos ULSBA Psychiatry Department ULSBA comprises several primary care services across the region a public health unit a Hospital as well as a palliative care community support team ULSBA is located in the largest district of Portugal district of Beja covering 104 of Portugals total area while serving the second least populated regional district area of Portugal with a population density 9 times lower than the national average Lower Alentejo and the district of Beja is a predominantly rural and relatively poor area with a high percentage of older adults declining population underdeveloped public transportation system and up until recently underserved in terms of mental healthcare assistance ULSBA has a long-standing history of community health prevention and promotion Specifically ULSBA has implemented a community-based mental health promotion program for older adults in social isolation that included strategies on how to cope with grief Leveraging on this expertise and in the context of LEAVES-PT ULSBA will contact community-dwelling older adults registered in primary care services in Lower Alentejo
Hypothesis
The investigators hypothesize that
1 a dialogue-based online self-help programme LEAVES intervention significantly decreases grief depression symptoms and perceived loneliness small to medium effect compared to the usual care control arm over 20 weeks in a clinical sample of Portuguese adults over 55
2 participants where the loss occurred more recently especially 6 months andor have more severe grief symptoms at baseline will benefit more from the LEAVES intervention
Objectives
To test these hypotheses the investigators aim to
1 determine the effectiveness of a 10-week intervention with LEAVES vs usual care control over 20 weeks in a pragmatic randomised two-armed parallel-group controlled trial on 1 Grief symptoms primary endpoint and 2 Depression symptoms and Loneliness secondary endpoints
2 determine if time since loss and severity of grief symptoms at baseline are moderators for the effectiveness of the intervention
Sample size
The investigators aim to recruit and randomise 100 participants where 50 participants will be allocated to each arm The intervention will last 10 weeks and participants will be followed for a further 10 weeks 20 weeks since baseline
Previously Brodbeck and colleagues found that an intervention with LIVIA a bereavement online support service in Swiss adults 40 years old had a large effect on grief d 081 compared to the control arm In Alentejo Portugal and in adults 55 years and over the investigators expect the LEAVES intervention to have a small to medium effect on grief d 030 as measured by TRIG vs usual care control arm To find a significant difference between intervention and control at 80 power and with an α of 005 assuming a correlation of 065 among repeated measurements and using ANOVA a total of 52 participants are necessary The investigators anticipate a dropout of 20 between recruitment and the start of the trial 10 weeks and a 30 dropout over the study duration 20 weeks In view of the sample size calculation the investigators aim to recruit at least 100 participants with 50 participants per arm Power calculations were done with GPower
Recruitment
Recruitment will be coordinated by ULSBA located in Beja Portugal by 4-6 clinical psychologists andor mental health nurses Participants registered with ULSBAs primary care services who are 55 years and over and widowed will be randomly contacted by clinical staff through telephone following a six-step model for optimal recruitment 1 explain the condition 2 reassure patients about receiving treatment 3 establish uncertainty 4 explain the study purpose 5 give a balanced view of treatments and 6 Explain study procedure The first 100 participants to accept to participate in LEAVES-PT will be screened according to the eligibility criteria and if included assigned a treatment If the investigators do not manage to recruit 100 participants the recruitment will be extended to other districts in Portugal besides Beja Participants will also be asked for the preferred place of assessment if in-person and at the hospital primary care centre or in-person and at their usual place of residence To minimize dropout and increase adherence participants will be contacted regularly to address troubleshooting or other technological issues
Data Collection and management
Besides the initial telephone risk assessment data on most variables will be collected through face-to-face interviews at the participants usual residency or at ULSBA however is more convenient for the participant Data on module completion duration and intensity of the LEAVES support service will be collected automatically within the online platform In accordance with the data minimisation principle the investigators certify that only variables indispensable for the trial will be collected All data will be stored and analysed in an anonymous and unidentifiable format in such a way that the database entries cannot be linked to the personal identity of the study participants Servers are protected by high-end firewall systems and only researchers directly involved in the study have access to the data
Statistical analysis
Data cleaning and quality control will be performed prior to analysis Normality will be assessed by Q-Q plots normally distributed variables will be presented as means and SDs non-Gaussian distributed variables as medians and interquartile ranges IQR and categorical data as percentages with corresponding frequency Missing value analysis will be carried out to explore the patterns the extent and the type of missing data Assuming that data will be missing at random linear mixed models will be used to determine the effectiveness of the intervention vs the control on grief symptoms over the 20 weeks of follow-up and using the intention-to-treat principle Models for the primary and secondary outcomes will have terms for time pre vs post intervention measures and post intervention vs follow-up measures group usual care vs LEAVES usual care possible non-randomised confounders and interaction terms As a sensitivity analysis LEAVES-PT will explore moderators such as sex age time since loss and severity of grief symptoms Cohens d will be calculated for all models Point estimates and confidence intervals will be used to assess statistical and clinical significance Results of the linear mixed models will be presented as βs and 95 confidence intervals CI
Cost-effectiveness analysis
The investigators will estimate the incremental cost-effectiveness ratio ICER of the intervention in terms of cost per point-improvement in the grief scale The investigators will also look at depression and loneliness secondary outcomes and estimate ICERs using improvements in the depression or loneliness scales in the denominator according to the following ICER cost of delivering the intervention total improvement in grief symptoms The investigators will adopt a provider perspective taking into account in the numerator the costs borne by the provider of the intervention The investigators will consider both technological equipment costs cost of using the platform and human costs training time spent by staff delivering the intervention associated with providing the intervention
Theoretical background
The death of a partner is a frequent and very stressful critical life event in later life It implies a dissolution of social and emotional ties This deeply affects the attachment system requires the acceptance of the loss as well as the formation of a new identity and a new perspective for the future It involves the adaptation of daily routines which can be even more challenging when social physical and financial resources decline in later life Grief and psychological distress after the loss of a partner are normative reactions For most people grief intensity weakens to a manageable degree within several weeks or months After the most intensive period grief is still present but the loss becomes gradually integrated and no longer hinders the way of ongoing life However some individuals are less able to cope with bereavement and show symptoms of disturbed or prolonged grief or adaptation problems About 10 of older adults develop a prolonged grief disorder or persistent complex bereavement disorder characterised by separation distress frequent or disabling cognitive emotional and behavioural symptoms such as avoidance of reminders of the loved one difficulties moving on with life and functional impairment The development of prolonged grief or adaptation problems often goes unnoticed by the widower who then fail to realize that help may be needed This leads to a situation in which older adults are unaware of their own needs do not seek help and do not receive the care needed Previous focus groups and stakeholders feedback have noted that Portuguese older adults who lost their partner and their family members avoid and downplay the grief process not seeking help when needed This may lead to a high usage of primary care and later on to mental health services with complaints of insomnia physical and depressive symptoms
A wide range of interventions are available for either preventing or treating prolonged grief disorder including support groups writing exercises and individual psychological counselling and more recently internet-based options Such interventions mostly consist of writing exercises with minimal therapist involvement Previously Brodbeck and colleagues found that a 12-week intervention with a bereavement online support service LIVIA in Swiss adults 40 years old had a medium to large effect on grief depression and loneliness over 3 months as well as increasing life satisfaction
Adapted from LIVIA and combining features from the Before you leave app LEAVES is an online self-help interactive programme founded in the task model of mourning and the dual-process model of coping with bereavement that supports older adults who have lost their partner in dealing with and preventing prolonged grief following a user-centred iterative and agile approach In LEAVES-PT the investigators will carry out a 10-week pragmatic randomised two-armed parallel-group controlled trial to compare the effectiveness of LEAVES vs usual care in reducing grief in community-dwelling Portuguese adults over 55 years registered with the local primary care unit Besides the clinical evaluation a qualitative study of implementation and engagement with the LEAVES online service and a cost-effectiveness analysis will be carried out This trial LEAVES-PT is part of a larger study from an international consortium LEAVES with two more trial centres but with distinct design and methodology The Netherlands and Switzerland
Context on Lower Alentejos Population and ULSBA
LEAVES-PT is coordinated by the Local Health Unit of Lower Alentejos ULSBA Psychiatry Department ULSBA comprises several primary care services across the region a public health unit a Hospital as well as a palliative care community support team ULSBA is located in the largest district of Portugal district of Beja covering 104 of Portugals total area while serving the second least populated regional district area of Portugal with a population density 9 times lower than the national average Lower Alentejo and the district of Beja is a predominantly rural and relatively poor area with a high percentage of older adults declining population underdeveloped public transportation system and up until recently underserved in terms of mental healthcare assistance ULSBA has a long-standing history of community health prevention and promotion Specifically ULSBA has implemented a community-based mental health promotion program for older adults in social isolation that included strategies on how to cope with grief Leveraging on this expertise and in the context of LEAVES-PT ULSBA will contact community-dwelling older adults registered in primary care services in Lower Alentejo
Hypothesis
The investigators hypothesize that
1 a dialogue-based online self-help programme LEAVES intervention significantly decreases grief depression symptoms and perceived loneliness small to medium effect compared to the usual care control arm over 20 weeks in a clinical sample of Portuguese adults over 55
2 participants where the loss occurred more recently especially 6 months andor have more severe grief symptoms at baseline will benefit more from the LEAVES intervention
Objectives
To test these hypotheses the investigators aim to
1 determine the effectiveness of a 10-week intervention with LEAVES vs usual care control over 20 weeks in a pragmatic randomised two-armed parallel-group controlled trial on 1 Grief symptoms primary endpoint and 2 Depression symptoms and Loneliness secondary endpoints
2 determine if time since loss and severity of grief symptoms at baseline are moderators for the effectiveness of the intervention
Sample size
The investigators aim to recruit and randomise 100 participants where 50 participants will be allocated to each arm The intervention will last 10 weeks and participants will be followed for a further 10 weeks 20 weeks since baseline
Previously Brodbeck and colleagues found that an intervention with LIVIA a bereavement online support service in Swiss adults 40 years old had a large effect on grief d 081 compared to the control arm In Alentejo Portugal and in adults 55 years and over the investigators expect the LEAVES intervention to have a small to medium effect on grief d 030 as measured by TRIG vs usual care control arm To find a significant difference between intervention and control at 80 power and with an α of 005 assuming a correlation of 065 among repeated measurements and using ANOVA a total of 52 participants are necessary The investigators anticipate a dropout of 20 between recruitment and the start of the trial 10 weeks and a 30 dropout over the study duration 20 weeks In view of the sample size calculation the investigators aim to recruit at least 100 participants with 50 participants per arm Power calculations were done with GPower
Recruitment
Recruitment will be coordinated by ULSBA located in Beja Portugal by 4-6 clinical psychologists andor mental health nurses Participants registered with ULSBAs primary care services who are 55 years and over and widowed will be randomly contacted by clinical staff through telephone following a six-step model for optimal recruitment 1 explain the condition 2 reassure patients about receiving treatment 3 establish uncertainty 4 explain the study purpose 5 give a balanced view of treatments and 6 Explain study procedure The first 100 participants to accept to participate in LEAVES-PT will be screened according to the eligibility criteria and if included assigned a treatment If the investigators do not manage to recruit 100 participants the recruitment will be extended to other districts in Portugal besides Beja Participants will also be asked for the preferred place of assessment if in-person and at the hospital primary care centre or in-person and at their usual place of residence To minimize dropout and increase adherence participants will be contacted regularly to address troubleshooting or other technological issues
Data Collection and management
Besides the initial telephone risk assessment data on most variables will be collected through face-to-face interviews at the participants usual residency or at ULSBA however is more convenient for the participant Data on module completion duration and intensity of the LEAVES support service will be collected automatically within the online platform In accordance with the data minimisation principle the investigators certify that only variables indispensable for the trial will be collected All data will be stored and analysed in an anonymous and unidentifiable format in such a way that the database entries cannot be linked to the personal identity of the study participants Servers are protected by high-end firewall systems and only researchers directly involved in the study have access to the data
Statistical analysis
Data cleaning and quality control will be performed prior to analysis Normality will be assessed by Q-Q plots normally distributed variables will be presented as means and SDs non-Gaussian distributed variables as medians and interquartile ranges IQR and categorical data as percentages with corresponding frequency Missing value analysis will be carried out to explore the patterns the extent and the type of missing data Assuming that data will be missing at random linear mixed models will be used to determine the effectiveness of the intervention vs the control on grief symptoms over the 20 weeks of follow-up and using the intention-to-treat principle Models for the primary and secondary outcomes will have terms for time pre vs post intervention measures and post intervention vs follow-up measures group usual care vs LEAVES usual care possible non-randomised confounders and interaction terms As a sensitivity analysis LEAVES-PT will explore moderators such as sex age time since loss and severity of grief symptoms Cohens d will be calculated for all models Point estimates and confidence intervals will be used to assess statistical and clinical significance Results of the linear mixed models will be presented as βs and 95 confidence intervals CI
Cost-effectiveness analysis
The investigators will estimate the incremental cost-effectiveness ratio ICER of the intervention in terms of cost per point-improvement in the grief scale The investigators will also look at depression and loneliness secondary outcomes and estimate ICERs using improvements in the depression or loneliness scales in the denominator according to the following ICER cost of delivering the intervention total improvement in grief symptoms The investigators will adopt a provider perspective taking into account in the numerator the costs borne by the provider of the intervention The investigators will consider both technological equipment costs cost of using the platform and human costs training time spent by staff delivering the intervention associated with providing the intervention
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