Symptom Management Program for Hemodialysis Patients

Study Overview
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Brief Summary
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Self-management intervention may decrease symptom burden and improve functioning over time.

Detailed Description
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Self-management intervention (strategies) may decrease symptom burden (sleep disturbance, tiredness; itching and numbness) and improve functioning (social, physical and emotional) over time(baseline, 3 weeks and 8 weeks).

Official Title
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Symptom Management Program for Hemodialysis Patients

Conditions
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Haemodialysis-induced Symptom

Intervention / Treatment
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* Behavioral: Self-management
* Behavioral: Dietary Information


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age ≥ 18 years old, on HD three times a week, received HD for ≥ six months, read and write English, have telephone service. Exclusion Criteria: history of dementia, acquired immunodeficiency syndrome (AIDS) and active cancer, and inability to give informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Self Management Strategies<br>Participants in the intervention group will receive printed self management strategies each of the 5 symptoms, a symptom diary with the self-management strategies and a 15 minutes discussion. The intervention script will instruct participants on how to use the printed strategies by PI and RA #1. Week 3. | Behavioral: Self-management<br>* Participants in the intervention group will receive printed self management strategies each of the 5 symptoms, a symptom diary with the self-management strategies and a 15 minutes discussion. The intervention script will instruct participants on how to use the printed strategies by PI and RA #1. Week 3<br>* Other names: Behavioral;|
| Active Comparator: Dietary Information<br>Control arm | Behavioral: Dietary Information<br>* The control or usual care group will receive a symptom diary designed for the control group without any strategies and a 5 minutes discussion on how to complete the diary from RA# 1. The PI will make weekly follow up calls on the same schedule as the intervention group starting week 4 until week 7 for a total of 4 calls focusing on enhancing healthy eating skills & adherence to renal diet and fluid restriction without discussing any intervention with the group.<br>* Other names: Behavioral;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease symptom burden | The study aims are: 1. To compare the differences between the self management intervention and control group on the following outcomes: Decreased symptoms: itching, tiredness, numbness, sleep disturbance (difficulty falling asleep & difficulty staying asleep); Adherence to treatment diary Improved social functioning, physical functioning and emotional status. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of implementing self management intervention | To evaluate the feasibility of implementing the self management intervention for a larger randomized controlled studyTreatment delivered (number of interventions sessions delivered and strategies used); Treatment receipts (understanding of strategies); and Treatment enactment (reported perception of usefulness of the strategies). | 5 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sleep disturbance, tiredness, itching & numbness