The Health Promoting Conversations for Families With a Critically Ill Relative
Primary Purpose
Family Health
Status
Terminated
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
The health-promoting conversations
Usual Care
Sponsored by
About this trial
This is an interventional supportive care trial for Family Health focused on measuring Family Relations, Family Health, Intervention study, Social support, Intensive care unit
Eligibility Criteria
Inclusion criteria:
- patient age >18 years
- patient treated in the ICU for at least 96 hours
- at least one family member (age >15 years) interested in participating
Exclusion criteria:
- dementia
- or other severe psychiatric illnesses
- drug abuse
- difficulties in understanding or reading the Swedish language
Sites / Locations
- Linköping university
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
The health-promoting conversations
Control Arm
Arm Description
In the intervention group, there were 3 health-promoting conversations with each family after the discharge. The health-promoting conversations were held within an approximately 4- to 8-week period with an interval of 2 weeks between conversations. A closing letter was sent 2 to 3 weeks after the final conversation that summarized all of the conversations and that provided further opportunities for reflection.
Usual Care
Outcomes
Primary Outcome Measures
family functioning
e GF is a 12-item scale designed to measure self-reported perceived overall 15 family functioning (Wright and Leahey, 2009, 2013). Each item is rated on a four-point 16 Likert scale: 'strongly agree' = 1, 'agree' = 2, 'disagree' = 3 and 'strongly disagree' = 4. The 17 scale scores ranges from 12 to 48, with lower scores indicating better family functioning. The 18 GF was translated into Swedish and has been pilot tested in Swedish samples, and the scale 19 has shown satisfactory reliability and acceptable validity of 0.90 (Bylund et al., 2015). The 20 reliability coefficient alpha was 0.45 in this study.
Secondary Outcome Measures
Full Information
NCT ID
NCT03325049
First Posted
September 15, 2017
Last Updated
February 22, 2021
Sponsor
Linkoeping University
1. Study Identification
Unique Protocol Identification Number
NCT03325049
Brief Title
The Health Promoting Conversations for Families With a Critically Ill Relative
Official Title
The Health Promoting Conversations Intervention for Families With a Critically Ill Relative: A Pilot RCT
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Terminated
Why Stopped
We have closed the study because of slow inclusion of families
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
January 16, 2019 (Actual)
Study Completion Date
January 16, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Linkoeping University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Objective: We investigated the outcomes of a nurse-led family intervention, Health Promoting Conversations, which focused on family functioning and wellbeing in families with a critically ill member.
Study design: This randomized controlled pilot study used a pre-test, post-test design with intervention and control groups to investigate the outcomes of the nurse-led intervention in 17 families.
Outcome measures: The Health Promoting Conversations intervention was evaluated using validated instruments that measure family functioning and family wellbeing: the General Functioning sub-scale from the McMaster Family Assessment Device; the Family Sense of Coherence, the Herth Hope Index, and the Medical Outcome Short-Form Health Survey. Descriptive and analytical statistical methods were used to analyse the data.
Detailed Description
This randomized control trial (RCT) used a pre-test, post-test design with intervention and control groups.
In the intervention group, there were 3 health-promoting conversations with each family after the discharge. The health-promoting conversations were held within an approximately 4- to 8-week period with an interval of 2 weeks between conversations. A closing letter was sent 2 to 3 weeks after the final conversation that summarized all of the conversations and that provided further opportunities for reflection.
Baseline data were collected to assess family functioning and wellbeing in the intervention group and the control group 1-2 months after the critical illness and before the start of the intervention. Follow-up assessments were conducted 3 and 12 months after the intervention for both groups. Additionally, background data, including health history, were collected using a self-administered questionnaire that asked about age; sex; education level; habits like smoking, alcohol consumption, and physical activity; psychosocial support; co-morbidity; and risk of mortality. The latter was calculated using the Charlson Comorbidity Index (Charlson et al., 1987).
The main outcome variables in this study were family functioning and family wellbeing. The following instruments were used in this study: 1) General Functioning (GF) sub-scale from the McMaster Family Assessment Device (FAD); 2) Family Sense of Coherence (F-SOC/F-KASAM); 3) Herth Hope Index (HHI); and 4) Medical Outcome Short-Form health survey (SF-36).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Family Health
Keywords
Family Relations, Family Health, Intervention study, Social support, Intensive care unit
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This randomized controlled pilot study used a pre-test, post-test design with intervention and control groups
Masking
None (Open Label)
Allocation
Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
The health-promoting conversations
Arm Type
Experimental
Arm Description
In the intervention group, there were 3 health-promoting conversations with each family after the discharge. The health-promoting conversations were held within an approximately 4- to 8-week period with an interval of 2 weeks between conversations. A closing letter was sent 2 to 3 weeks after the final conversation that summarized all of the conversations and that provided further opportunities for reflection.
Arm Title
Control Arm
Arm Type
Active Comparator
Arm Description
Usual Care
Intervention Type
Behavioral
Intervention Name(s)
The health-promoting conversations
Intervention Description
The health-promoting conversations
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
Usual Care
Primary Outcome Measure Information:
Title
family functioning
Description
e GF is a 12-item scale designed to measure self-reported perceived overall 15 family functioning (Wright and Leahey, 2009, 2013). Each item is rated on a four-point 16 Likert scale: 'strongly agree' = 1, 'agree' = 2, 'disagree' = 3 and 'strongly disagree' = 4. The 17 scale scores ranges from 12 to 48, with lower scores indicating better family functioning. The 18 GF was translated into Swedish and has been pilot tested in Swedish samples, and the scale 19 has shown satisfactory reliability and acceptable validity of 0.90 (Bylund et al., 2015). The 20 reliability coefficient alpha was 0.45 in this study.
Time Frame
up to 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
patient age >18 years
patient treated in the ICU for at least 96 hours
at least one family member (age >15 years) interested in participating
Exclusion criteria:
dementia
or other severe psychiatric illnesses
drug abuse
difficulties in understanding or reading the Swedish language
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susanna Ågren, PhD
Organizational Affiliation
Linkoeping University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Linköping university
City
Linköping
ZIP/Postal Code
S-58183
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
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The Health Promoting Conversations for Families With a Critically Ill Relative
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