NCT05466773

Brief Summary

The investigator aim to evaluate the effect of training program on treatment adherence, quality of life, cardiovascular risk factors, depression, and healthcare utilization. The investigator conducted a quasi experimental study. The investigator also examine the effect of interaction between health literacy and training program on depression, treatment adherence, cardiovascular risk factors, quality of life, and healthcare utilization. The ultimate goal is to improve the dietary intake and dialysis outcomes for all hemodialysis patients in Taiwan. The investigator therefore will the SaaS dietary educational platform for this purpose.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
141

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2019

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

July 14, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 20, 2022

Completed
Last Updated

July 20, 2022

Status Verified

July 1, 2022

Enrollment Period

3.2 years

First QC Date

July 14, 2022

Last Update Submit

July 18, 2022

Conditions

Hemodialysis Complication

Keywords

hemodialysis, nutrition education

Outcome Measures

Primary Outcomes (1)

  • Health Literacy

    Health literacy will be also measured by Chew's 3 brief health literacy screening questions (BHLS), each with 5 possible response options: (1) "How often do you have problems learning about your medical condition because of difficulty understanding written information?" (always, often, sometimes, occasionally, or never); (2) "How often do you have someone help you read hospital materials?" (always, often, sometimes, occasionally, or never); and (3) "How confident are you filling out medical forms by yourself?" (extremely, quite a bit, somewhat, a little bit, or not at all).

    baseline

Secondary Outcomes (1)

  • Dietary knowledge

    2 months

Other Outcomes (5)

  • Treatment adherence-biological markers

    4 months

  • Treatment adherence-hemodialysis treatment

    4 months

  • Mental health

    4 months

  • +2 more other outcomes

Study Arms (4)

CN group

EXPERIMENTAL

Giving nutrition education for nurse, but not for patients

Behavioral: Hemodialysis eating index (HDEI) base education intervention

CP group

EXPERIMENTAL

Giving nutrition education for patients, but not for nurses

Behavioral: Hemodialysis eating index (HDEI) base education intervention

CNP group

EXPERIMENTAL

Giving nutrition education for both patients and nurses

Behavioral: Hemodialysis eating index (HDEI) base education intervention

NC group

NO INTERVENTION

No nutrition education for patients and nurses

Interventions

Hemodialysis eating index (HDEI) base education interventionBEHAVIORAL

The investigators have developed the educational materials for patients, in order to improve the dialysis outcomes. The interventions will be delivered to patients and nurses in hospital based hemodialysis centers.

CN groupCNP groupCP group

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hemodialysis patients whose aged 20-75 years, received hemodialysis treatment thrice a week for at least 3 months, the education level of junior high school and higher, and Kt/V \> 1.2.

You may not qualify if:

  • Hemodialysis patients with obvious edema, pregnancy, amputation, hyperthyroidism, hypothyroidism, malignancy, liver failure or cancer, mental disorders, tube feeding, hospitalization and plan to surgery, loss to measure body composition, and percentage body fat \< 4% were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Medical University

Taipei, Other (Non U.s.), 11669, Taiwan

Location

Related Publications (10)

  • Chew LD, Bradley KA, Boyko EJ. Brief questions to identify patients with inadequate health literacy. Fam Med. 2004 Sep;36(8):588-94.

    PMID: 15343421BACKGROUND

  • Cavanaugh KL, Osborn CY, Tentori F, Rothman RL, Ikizler TA, Wallston KA. Performance of a brief survey to assess health literacy in patients receiving hemodialysis. Clin Kidney J. 2015 Aug;8(4):462-8. doi: 10.1093/ckj/sfv037. Epub 2015 Jun 10.

    PMID: 26251719BACKGROUND

  • Wallace LS, Rogers ES, Roskos SE, Holiday DB, Weiss BD. Brief report: screening items to identify patients with limited health literacy skills. J Gen Intern Med. 2006 Aug;21(8):874-7. doi: 10.1111/j.1525-1497.2006.00532.x.

    PMID: 16881950BACKGROUND

  • Duff EA, Chawke FM. A service review to assess if innovative intensive phosphate dietary education can help reduce phosphate levels to the recommended range in a hemodialysis population. Hemodial Int. 2017 Oct;21 Suppl 2:S22-S26. doi: 10.1111/hdi.12593.

    PMID: 29064180BACKGROUND

  • Kim Y, Evangelista LS, Phillips LR, Pavlish C, Kopple JD. The End-Stage Renal Disease Adherence Questionnaire (ESRD-AQ): testing the psychometric properties in patients receiving in-center hemodialysis. Nephrol Nurs J. 2010 Jul-Aug;37(4):377-93.

    PMID: 20830945BACKGROUND

  • Hays RD, Kallich JD, Mapes DL, Coons SJ, Carter WB. Development of the kidney disease quality of life (KDQOL) instrument. Qual Life Res. 1994 Oct;3(5):329-38. doi: 10.1007/BF00451725.

    PMID: 7841967BACKGROUND

  • Wan EY, Chen JY, Choi EP, Wong CK, Chan AK, Chan KH, Lam CL. Patterns of health-related quality of life and associated factors in Chinese patients undergoing haemodialysis. Health Qual Life Outcomes. 2015 Jul 29;13:108. doi: 10.1186/s12955-015-0308-3.

    PMID: 26215978BACKGROUND

  • Joshi VD, Mooppil N, Lim JF. Validation of the kidney disease quality of life-short form: a cross-sectional study of a dialysis-targeted health measure in Singapore. BMC Nephrol. 2010 Dec 20;11:36. doi: 10.1186/1471-2369-11-36.

    PMID: 21172008BACKGROUND

  • Macfarlane DJ, Lee CC, Ho EY, Chan KL, Chan DT. Reliability and validity of the Chinese version of IPAQ (short, last 7 days). J Sci Med Sport. 2007 Feb;10(1):45-51. doi: 10.1016/j.jsams.2006.05.003. Epub 2006 Jun 30.

    PMID: 16807105BACKGROUND

  • Liou YM, Jwo CJ, Yao KG, Chiang LC, Huang LH. Selection of appropriate Chinese terms to represent intensity and types of physical activity terms for use in the Taiwan version of IPAQ. J Nurs Res. 2008 Dec;16(4):252-63. doi: 10.1097/01.jnr.0000387313.20386.0a.

    PMID: 19061172BACKGROUND

Study Officials

  • Shwu-Huey Yang, Ph.D

    Taipei Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: quasi-experimental design with 4 groups
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 14, 2022

First Posted

July 20, 2022

Study Start

May 1, 2019

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

July 20, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

We need more time to clear the data.

Locations

TW(1)