The Health Promoting Conversations for Families With a Critically Ill Relative

NCT03325049 | Terminated

• 1 other identifier: LinkoepingU74
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Family Health

Keywords

Family Relations; Family Health; Intervention study; Social support; Intensive care unit

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 12 months

Study Arms (2)

The health-promoting conversations

EXPERIMENTAL

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.

Behavioral: The health-promoting conversations

Control Arm

ACTIVE COMPARATOR

Usual Care

Other: Usual Care

Interventions

The health-promoting conversations BEHAVIORAL

The health-promoting conversations

The health-promoting conversations

Usual Care OTHER

Usual Care

Control Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• dementia
• or other severe psychiatric illnesses
• drug abuse
• difficulties in understanding or reading the Swedish language

Sponsors & Collaborators

• Linkoeping University: lead

Study Sites (1)

Linköping university

Linköping, S-58183, Sweden

Location

Related Publications (39)

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Study Officials

• Susanna Ågren, PhD

  Linkoeping University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the project

Model Details: This randomized controlled pilot study used a pre-test, post-test design with intervention and control groups

Study Record Dates

• First Submitted: September 15, 2017
• First Posted: October 30, 2017
• Study Start: September 1, 2017
• Primary Completion: January 16, 2019
• Study Completion: January 16, 2020
• Last Updated: February 24, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)