Effects of a Brief Hope Intervention to the Decision Making

NCT03378700 | Unknown DMC

• 1 other identifier: HSEARS2018
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

CKD; Hope Intervention; decision making

Outcome Measures

Primary Outcomes (1)

• Decision Making Profile and Decisional Conflict Scale (DCS)

  The scale was recommended in Shared Decision-making Programme of the U.K. National Health Services (National Health Service \& Capita Group, 2012). It is a 16-items tool that consists of five subscales rated on a 5-point Likert scale. Reliability of DCS is good (Cronbach's alpha = .78) and construct validity discriminating between known groups (effect size .4-.8), and responsiveness to change is good in studies of decision supporting interventions (ES .4-1.2) (O'Connor, 2010).

  3 months

Secondary Outcomes (4)

• Strength of Preference (SP)

  3 months

• State Hope Scale (SHS)

  3 months

• Kidney Disease Quality of Life Questionnaire (KDQOL-36) Cantonese Chinese Version

  3 months

• Healthcare Resource Utilisation Data

  3 months

Study Arms (2)

Brief Hope Intervention Group

EXPERIMENTAL

In addition to the pre-dialysis educational programme on self-care and treatment options for ESRF patients as per the control group, brief hope intervention will be offered: a four-weeks individual intervention. Two face-to-face sessions (1-hour) and two telephone follow up sessions (30 minutes) in between. A booklet modified from the goal worksheet in Lopez et al. (2000) will be prepared for the participants for reviewing their planned goals, recording achieved targets and successful experiences.

Behavioral: Brief Hope Intervention

Pre-dialysis Education Group

ACTIVE COMPARATOR

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

Other: Pre-dialysis Education Group

Interventions

Brief Hope Intervention BEHAVIORAL

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.

Brief Hope Intervention Group

Pre-dialysis Education Group OTHER

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

Pre-dialysis Education Group

Eligibility Criteria

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

You may qualify if:

• The candidates should meet the below criteria will be recruited.
• age ≥ 18 years
• clinically diagnosed to have End Stage Renal Diseae (ESRD) and Glomerular Filtration Rate (GFR) less than or equal to 15
• willing to participate in face-to-face activities and telephone follow up
• alert and oriented, able to sustain for approximately one hour of attention and interaction
• communicable in Cantonese, able to read and write Chinese
• could be reached by phone

You may not qualify if:

• Patients having one or above of the below conditions will be excluded from the study.
• patients who have been receiving renal replacement therapy
• patients who have failed kidney transplant
• patients who are unable to communicate in Cantonese
• patient who has hearing deficit
• Patient who are disoriented, delirious or cognitively impaired
• patients who are clinically depressed diagnosed by medical doctors

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead
• Kwong Wah Hospital: collaborator

Related Publications (1)

• Chan K, Wong FKY, Tam SL, Kwok CP, Fung YP, Wong PN. Effectiveness of a brief hope intervention for chronic kidney disease patients on the decisional conflict and quality of life: a pilot randomized controlled trial. BMC Nephrol. 2022 Jun 14;23(1):209. doi: 10.1186/s12882-022-02830-7.

  PMID: 35701732 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kitty Chan, PhD

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kitty Chan, PhD

CONTACT

27666883; kitty.yy.chan@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The principal investigator and the nurse providing the intervention are aware of the patient group assignment. Assessment of the baseline and endpoints of the patient outcomes will be performed by an independent research assistant blinded to group allocation, who was not involved in the intervention.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 a brief hope intervention (BHI) or the control group using sets of computer-generated random numbers.

Study Record Dates

• First Submitted: December 7, 2017
• First Posted: December 20, 2017
• Study Start: April 1, 2018
• Primary Completion: December 31, 2018
• Study Completion: May 30, 2019
• Last Updated: December 20, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share