Chronic Kidney DiseasesNCT03378700
Effects of a Brief Hope Intervention to the Decision Making
A study testing Brief Hope Intervention and Pre-dialysis Education Group in people with Chronic Kidney Diseases, run by The Hong Kong Polytechnic University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- Brief Hope Intervention and Pre-dialysis Education Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2018to 30 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation on the Effects of a Brief Hope Intervention to the Decision Making in the Chinese Chronic Kidney Disease Patients on Their Management Options: a Randomised Controlled Trial
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.
Read more
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.
Read the detailed description
Decision Making in Patients with Chronic Kidney Disease Patients with chronic kidney disease (CKD) stage 5 (estimated creatinine clearance equal to or less than 15 mL/min/1.73 m2), would face tough decisions on their treatment options when they were discovered to have end stage renal disease (ESRD), as their decisions affected their long term QoL. In general, when patients reach stage 4 CKD, taking into the account of the other symptoms and complications, dialysis initiation would be discussed. Peritoneal dialysis (PD) first policy has been adopted in the Hong Kong public health care system since 1985. It showed comparable patient survival outcomes to haemodialyis and early preservation of residual kidney functions. Nonetheless, a Hong Kong study found that more than half of these patients declined PD and preferred receiving palliative care. For those who decided to have conservative treatment may require urgent dialysis when their symptoms deteriorated such as dyspnoea. These patients may have decisional regret and would like to revert their initial choice. As such, helping patients to rigorously consider their preferences and concern is crucial.
Quality Decision Making Decision-making to commence or decline renal therapy in ESRD is a complex and dynamic process and evolves over time. It was found that planned dialysis in predialytic stage of CKD could reduce hospitalization duration, economic costs, mortality and improves QoL and depression. Standard pre-dialysis consultations, providing information on comparative risks, benefits and alternatives appeared inadequate to guide individualized decisions that are affected by personal values and perceptions. In a similar vein, a randomised control trial on asymptomatic abdominal aortic aneurysm on increasing patients' knowledge about the disorder and better informed them about elective surgery or watchful waiting did not reduce decisional conflict. Despite good knowledge, irrational choices were made. Patients felt that they have autonomy and were offered a treatment alternative if the consultation stimulated them to think of additional questions before making a decision. Some patients tried to take control of their progressive status of renal failure, while others tried to take control of their emotions. Determining the patients' readiness and facilitating patients to express their struggles to make value congruent decisions require more than a health education. Subsequent motivation after nephrology consultation become a vital step to enable these patients to initiate planned dialysis.
The Importance of Hope to Quality Decision Making Hope theory is adopted as the framework in the present study, where hope was believed as the central agent to facilitate the change process. By increasing hope level, the likelihood of therapeutic change will be increased. It is hypothesized that increasing hope would lead to selecting PD as recommended, stronger decision to the treatment, less decisional conflict and reduced emergency room visits or hospitalisation . Patients facing chronic illnesses would lead to psychological stress, anxiety, depression, fear and hopelessness. Prognostic uncertainty, subjective perception of a worsening health status, experience of quality of life, and even a sense of abandonment were expressed in the patients with chronic kidney diseases. Both depression and hopelessness was documented in renal failure patients. In a systematic review, cognitive appraisal was also found to have the largest effect size that associate with depression in patients with ESRD. Another systematic review and thematic synthesis also revealed five themes of concerns; (1) invasive suffering, such as loss of independence, treatment burden and harm, (2) personal vulnerability such as autonomy and dignity, (3) relational responsibility, for instance, protecting others from grief, (4) existential tensions such as preserving self-identity, and (5) preparedness, for example, decisional clarity, spirituality and hope. As such, both cognitive and emotional strategies should be integrated to facilitate effective decision making.
Despite the mechanisms by which positive emotions impact on decision making are not clearly understood, it was found that positive affect leads to efficient and thorough decision-making , that applied to physician's diagnostic process. It has been found that hope is one of the diverse positive emotions, which could lead to consideration of wider alternatives. Thus, it may lead to a more thorough exploration of the treatment options and consequences during the decision making process. Evidence has shown that high-hope individuals were found to be more creative and effective problem solvers. It is timely to translating these findings to wider clinical perspectives to enhance quality decision-making. Whether improving the hopeful state of patients with ESRF would lead to decrease decisional conflict or regrets remains under explored. Investigating whether improving the hopeful state of CKD patients would lead to better health outcomes will advance the application of hope in clinical interventions. The present study aimed to investigate the effect of brief hope therapy on the patients with stage 5 CKD when renal dialysis is recommended.
Hope Intervention Hope therapy that based on Snyder's conceptualization of hope is adopted in the present study. Three core features: (1) goal setting (goals), (2) problem solving (pathways) and (3) positive self-talk (agency), underlie the key hope strategies used in the intervention. Hope therapy is delivered within the principles of cognitive behavioural therapy (CBT), but its focus complemented the traditional CBT by shifting the primary focus on positive potentials, thereby promoting meaning in life, fostering personal strengths and positive changes. Despite the controversy about hope interventions lies on being overly optimistic is harmful, nurturing hope was found to be one of the significant elements in staying positive in the coping experiences of Chinese cancer patients. More importantly, hope is a pursuit toward a desirable future openness to possibilities, affirmation and reflection about one's capacity to reach self-established goals, and engagement in actions to make a difference in the outcome.
- Conditions
- Chronic Kidney Diseases
- Being tested
- Brief Hope Intervention, Pre-dialysis Education Group
- Keywords
- CKD, Hope Intervention, decision making
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Hope InterventionBehavioural
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.
Pre-dialysis Education GroupOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: Pre-dialysis Education Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3 months
Secondary outcomes (4)
Strength of Preference (SP)
This is a single item, 4 point Likert scale, ranging from 1 (weak preference) to 4 (very strong preference), that measures the strength of preferred treatment option (Stalmeier \& Roosmalen, 2009). A value of zero was designated to indicate 'undecided'.
Measured: 3 months
State Hope Scale (SHS)
The SHS Chinese version (Mak, Ng, \& Wong, 2011) is a self-report instrument consisting of 6 items (Snyder et al., 1996) used to assess the two ongoing hope indices related to the pathways and agency of hopeful thinking. It is rated on an 8-point scale with 1 = definitely false and 8 = definitely true. Cronbach's alpha for these two subscale items ranged from 0.74 to 0.93 (all ps < 0.001).
Measured: 3 months
Kidney Disease Quality of Life Questionnaire (KDQOL-36) Cantonese Chinese Version
This self-reported disease-targeted instrument is specific for assessing the health-related QoL of CKD patients (Chow \& Tam, 2014). It comprises of three subscales (24 items): (1) Symptoms and Problems (12 items), (2) Burden of Kidney Disease (4 items), and (3) Effects of Kidney Disease (8 items). Another 12 items were adopted from the Short Form Health Survey (SF12), which comprises of two sub-scores of Physical Component Summary (PCS) and Mental Component Summary (MCS). The higher the scores indicating better QoL. The Chinese version reported an overall internal consistency ranged from 0.72-0.94, while the intra-class correlation (ICC) test-retest reliability is 0.81-0.96 in the various domains (Tao, Chow, \& Wong, 2014).
Measured: 3 months
Healthcare Resource Utilisation Data
This profile reflects the complex and dynamic situation of QoL in CKD participants.
Three health services utilization indicators will be collected for a period of three months to determine their association with the subjective measures.
- the number of hospital readmissions (number of times within 30 days after discharge),
- emergency room visits (the lower the number, the lesser the need),
- recommended treatment choice, patients' initial and final treatment choice
- refusal to dialysis initially and reverting to dialysis from palliative treatment
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2017
- Study start1 Apr 2018 (estimated)
- Primary completion31 Dec 2018 (estimated)
- Study completion30 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- Kwong Wah Hospital
- Responsible party
- Sponsor
- Investigators
- Kitty Chan, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03378700
- Sponsor's protocol ID
- HSEARS2018
- Status last verified
- Aug 2017
- First submitted
- 7 Dec 2017
- Last updated
- 20 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35701732
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation on the Effects of a Brief Hope Intervention to the Decision Making in the Chinese Chronic Kidney Disease Patients on Their Management Options: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03378700
- Acronym / sponsor ID
- HSEARS2018
- Conditions
- Chronic Kidney Diseases
- Keywords
- CKD, Hope Intervention, decision making
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- Kwong Wah Hospital
- Study start
- 1 Apr 2018 (estimated)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 30 May 2019 (estimated)
- First posted
- 20 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Decision Making in Patients with Chronic Kidney Disease Patients with chronic kidney disease (CKD) stage 5 (estimated creatinine clearance equal to or less than 15 mL/min/1.73 m2), would face tough decisions on their treatment options when they were discovered to have end stage renal disease (ESRD), as their decisions affected their long term QoL. In general, when patients reach stage 4 CKD, taking into the account of the other symptoms and complications, dialysis initiation would be discussed. Peritoneal dialysis (PD) first policy has been adopted in the Hong Kong public health care system since 1985. It showed comparable patient survival outcomes to haemodialyis and early preservation of residual kidney functions. Nonetheless, a Hong Kong study found that more than half of these patients declined PD and preferred receiving palliative care. For those who decided to have conservative treatment may require urgent dialysis when their symptoms deteriorated such as dyspnoea. These patients may have decisional regret and would like to revert their initial choice. As such, helping patients to rigorously consider their preferences and concern is crucial.
Quality Decision Making Decision-making to commence or decline renal therapy in ESRD is a complex and dynamic process and evolves over time. It was found that planned dialysis in predialytic stage of CKD could reduce hospitalization duration, economic costs, mortality and improves QoL and depression. Standard pre-dialysis consultations, providing information on comparative risks, benefits and alternatives appeared inadequate to guide individualized decisions that are affected by personal values and perceptions. In a similar vein, a randomised control trial on asymptomatic abdominal aortic aneurysm on increasing patients' knowledge about the disorder and better informed them about elective surgery or watchful waiting did not reduce decisional conflict. Despite good knowledge, irrational choices were made. Patients felt that they have autonomy and were offered a treatment alternative if the consultation stimulated them to think of additional questions before making a decision. Some patients tried to take control of their progressive status of renal failure, while others tried to take control of their emotions. Determining the patients' readiness and facilitating patients to express their struggles to make value congruent decisions require more than a health education. Subsequent motivation after nephrology consultation become a vital step to enable these patients to initiate planned dialysis.
The Importance of Hope to Quality Decision Making Hope theory is adopted as the framework in the present study, where hope was believed as the central agent to facilitate the change process. By increasing hope level, the likelihood of therapeutic change will be increased. It is hypothesized that increasing hope would lead to selecting PD as recommended, stronger decision to the treatment, less decisional conflict and reduced emergency room visits or hospitalisation . Patients facing chronic illnesses would lead to psychological stress, anxiety, depression, fear and hopelessness. Prognostic uncertainty, subjective perception of a worsening health status, experience of quality of life, and even a sense of abandonment were expressed in the patients with chronic kidney diseases. Both depression and hopelessness was documented in renal failure patients. In a systematic review, cognitive appraisal was also found to have the largest effect size that associate with depression in patients with ESRD. Another systematic review and thematic synthesis also revealed five themes of concerns; (1) invasive suffering, such as loss of independence, treatment burden and harm, (2) personal vulnerability such as autonomy and dignity, (3) relational responsibility, for instance, protecting others from grief, (4) existential tensions such as preserving self-identity, and (5) preparedness, for example, decisional clarity, spirituality and hope. As such, both cognitive and emotional strategies should be integrated to facilitate effective decision making.
Despite the mechanisms by which positive emotions impact on decision making are not clearly understood, it was found that positive affect leads to efficient and thorough decision-making , that applied to physician's diagnostic process. It has been found that hope is one of the diverse positive emotions, which could lead to consideration of wider alternatives. Thus, it may lead to a more thorough exploration of the treatment options and consequences during the decision making process. Evidence has shown that high-hope individuals were found to be more creative and effective problem solvers. It is timely to translating these findings to wider clinical perspectives to enhance quality decision-making. Whether improving the hopeful state of patients with ESRF would lead to decrease decisional conflict or regrets remains under explored. Investigating whether improving the hopeful state of CKD patients would lead to better health outcomes will advance the application of hope in clinical interventions. The present study aimed to investigate the effect of brief hope therapy on the patients with stage 5 CKD when renal dialysis is recommended.
Hope Intervention Hope therapy that based on Snyder's conceptualization of hope is adopted in the present study. Three core features: (1) goal setting (goals), (2) problem solving (pathways) and (3) positive self-talk (agency), underlie the key hope strategies used in the intervention. Hope therapy is delivered within the principles of cognitive behavioural therapy (CBT), but its focus complemented the traditional CBT by shifting the primary focus on positive potentials, thereby promoting meaning in life, fostering personal strengths and positive changes. Despite the controversy about hope interventions lies on being overly optimistic is harmful, nurturing hope was found to be one of the significant elements in staying positive in the coping experiences of Chinese cancer patients. More importantly, hope is a pursuit toward a desirable future openness to possibilities, affirmation and reflection about one's capacity to reach self-established goals, and engagement in actions to make a difference in the outcome.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Brief Hope Intervention Group | Experimental | Behavioral: Brief Hope InterventionIn 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. |
| Pre-dialysis Education Group | Active comparator | Other: Pre-dialysis Education GroupPre-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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief Hope InterventionThe 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. | Behavioural | Brief Hope Intervention Group |
| Pre-dialysis Education GroupPre-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 |
Primary outcome
Decision Making Profile and Decisional Conflict Scale (DCS)
Time frame: 3 months
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).
4 secondary outcomes
Strength of Preference (SP)
Time frame: 3 months
State Hope Scale (SHS)
Time frame: 3 months
Kidney Disease Quality of Life Questionnaire (KDQOL-36) Cantonese Chinese Version
Time frame: 3 months
Healthcare Resource Utilisation Data
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2017.
- Derived from this study: PubMed 35701732Chan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kitty Chan, PhD principal investigator
The Hong Kong Polytechnic University
Questions about this trial
What is this clinical trial studying?
A study testing Brief Hope Intervention and Pre-dialysis Education Group in people with Chronic Kidney Diseases, run by The Hong Kong Polytechnic University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kitty Chan, PhD (27666883, kitty.yy.chan@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decision Making Profile and Decisional Conflict Scale (DCS) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03378700, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2017.