Clinical Trials Directory

Trials / Terminated

TerminatedNCT03325049

The Health Promoting Conversations for Families With a Critically Ill Relative

The Health Promoting Conversations Intervention for Families With a Critically Ill Relative: A Pilot RCT

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
17 (actual)
Sponsor
Linkoeping University · Other Government
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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).

Conditions

Interventions

TypeNameDescription
BEHAVIORALThe health-promoting conversationsThe health-promoting conversations
OTHERUsual CareUsual Care

Timeline

Start date
2017-09-01
Primary completion
2019-01-16
Completion
2020-01-16
First posted
2017-10-30
Last updated
2021-02-24

Locations

1 site across 1 country: Sweden

Source: ClinicalTrials.gov record NCT03325049. Inclusion in this directory is not an endorsement.