Haemodialysis-induced Symptom
Conditions
Keywords
sleep disturbance, tiredness, itching & numbness
Brief summary
Self-management intervention may decrease symptom burden and improve functioning over time.
Detailed description
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).
Interventions
BEHAVIORALSelf-management
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
BEHAVIORALDietary Information
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.
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. age ≥ 18 years old, 2. on HD three times a week, 3. received HD for ≥ six months, 4. read and write English, 5. have telephone service.
Exclusion criteria
* history of dementia, * acquired immunodeficiency syndrome (AIDS) and active cancer, and * inability to give informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Decrease symptom burden | 8 weeks | The study aims are: 1\. To compare the differences between the self management intervention and control group on the following outcomes: 1. Decreased symptoms: itching, tiredness, numbness, sleep disturbance (difficulty falling asleep & difficulty staying asleep); 2. Adherence to treatment diary Improved social functioning, physical functioning and emotional status. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of implementing self management intervention | 5 weeks | 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). |
Countries
United States
Outcome results
None listed