Effects of a Brief Hope Intervention to the Decision Making

NCT03378700 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2017-12-20

No results posted yet for this study

Summary

Introduction A Hong Kong study found that more than half of the chronic kidney disease (CKD) patients declined peritoneal dialysis (PD) and preferred receiving palliative care, although PD is vital for early preservation of residual kidney functions. Decision-making was found to be influenced by feelings of hopelessness, leading to underestimation and the pursuit of a successful plan of action. Cumulative evidences revealed that hope is a factor that heightens positive expectations in patients, and could lead to consideration of wider alternatives and thorough decision making.

Aim The aim of this study is to examine the effectiveness of a brief hope intervention in reducing the decisional conflict and improving the quality of life of CKD patients who have to plan for receiving dialysis therapy. If patients' quality of decision-making could be improved, timely initiation dialysis and less decisional regret is expected.

Method This study is a single-blinded randomised controlled trial. On completion of the baseline assessment and the screening procedure, eligible participants will be randomly assigned in equal number into either the experimental group (education programme plus a brief hope intervention) or the control group (education programme) using sets of computer-generated random numbers.

Patients attending the outpatient renal clinic of a regional hospital in HK will be approached. Stage 5 CKD patients (GRF equal to or less than 15) who are planned to receive dialysis therapy or palliative care will be invited to join the study. Taking into consideration of attrition and the health status of the palliative care patients, it was appropriate to sign up 36 participants per arm, correlation alpha value 0.6, 0.5 effect size with a power of 0.70.

There are four waves of data collection, which will be done before the commencement of the intervention (T1), immediately post-intervention (T2) and one month (T3) and three months (T4) after the completion of programme. Primary Outcomes include the assessing the patients' decisional conflict, strength of preference, on their choice of treatment modalities between peritoneal dialysis and palliative care, and health resources utilization. Secondary outcomes measure hope level change and quality of life. Sociodemographic and socioeconomic information will be collected. Two open-ended questions will be used to explore the perceived impact and benefits of the intervention.

Conditions

  • Chronic Kidney Diseases

Interventions

BEHAVIORAL

Brief Hope Intervention

The present Brief Hope Intervention (BHI) is a four-weeks individual intervention, consisting of four sessions: two face-to-face sessions (1-hour) and two telephone follow up sessions (30 minutes) in between. The facilitator will guide participants to imagine how they navigate themselves to circumvent possible obstacles and accomplished their set goals and experience positive emotions. A booklet will be given to the participants for reviewing their planned goals, recording achieved targets and successful experiences.

OTHER

Pre-dialysis Education Group

Pre-dialysis educational class and standard care such as clinic follow up and normal hospital care will be provided. This session is led by clinicians with renal nursing training. The educational class aims at providing information on the treatment modalities for patients with ESRD, signs and symptoms of their illness and the basic advice on the importance of adherence to healthy lifestyle, nutrition and medications. Logistic call and social communication will be offered and initiated by trained nurses in the second week and the third week

Sponsors & Collaborators

  • Kwong Wah Hospital

    collaborator OTHER
  • The Hong Kong Polytechnic University

    lead OTHER

Principal Investigators

  • Kitty Chan, PhD · The Hong Kong Polytechnic University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-01
Primary Completion
2018-12-31
Completion
2019-05-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03378700 on ClinicalTrials.gov