Behavioral Intervention and Adherence in Dialysis

May 26, 2015 updated by: Alan J. Christensen, University of Iowa

The aim of the proposed work is to conduct a randomized controlled trial (RCT) evaluation of a behavior change intervention designed to enhance fluid-intake adherence (compliance) among hemodialysis patients. Patient non-adherence (non-compliance) with fluid-intake restrictions is a highly pervasive problem in the hemodialysis population with substantial consequences in terms of increased patient morbidity and mortality. Given the prevalence and clinical importance of adherence among ESRD patients, the design and evaluation of interventions to improve patient adherence is critically important. Surprisingly, however, little such empirical work has been conducted in this area.

The proposed RCT involves testing the efficacy of a behaviorally based, group-administered, "behavioral self regulation" intervention designed to increase adherence to fluid intake restrictions among hemodialysis patients. This structured intervention is designed to be delivered by healthcare providers in a clinical setting to groups of 4-10 patients over seven, one-hour weekly sessions. This study will compare the effect of the structured intervention group with the effect of an educational and support group on fluid-intake adherence in a sample of approximately 200 fluid non-adherent center hemodialysis patients over a 26-week follow-up period. Both clinical (interdialysis session weight gain) and self-report indices of fluid-intake adherence will be examined. We believe that the proposed research is of potentially very high impact given the high prevalence and clear clinical consequences of hemodialysis patient nonadherence and the potential for a relatively low-cost, structured intervention to significantly reduce this type of maladaptive patient behavior in the hemodialysis treatment context.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Upon consent and enrollment into the study, patients will be given a packet of questionnaires to take home, complete, and return using a postage-paid envelope. These questionnaires will include a patient background form, which includes information on age, gender, marital status, years of education, employment status, and race/ethnicity, and two measure of health beliefs and attitudes (the Krantz Health Opinion Survey and the Multidimensional Health Locus of Control Scale. A copy of all measures in attached to this application.

Following consent and randomization participants will be assigned to one of two comparison study arms. Both study arms involve participation in a weekly, hour-long, patient support group for seven weeks. As described below the groups differ in terms of the content focus.

Patients randomly assigned to the Self-Regulation arm will meet in groups of 4-10 participants at their usual hemodialysis clinic for hour-long weekly sessions for seven weeks. Two to four groups will be conducted at each participating center depending on center size. Groups will be led by a member of the UIHC research team with at least two years previous professional experience with behavior change techniques, at least two years previous experience with the hemodialysis population, and a master's or doctoral level degree in psychology. Each UIHC team group leader will be responsible for 3-4 groups over the duration of the project. Session material utilized by group-leaders will be highly structured and detailed across the seven sessions. Self-Regulation group sessions will be generally highly leader-directed though participants will be regularly encouraged to share their experiences dealing with the dialysis regimen. A consistent attempt will be made to focus all group discussion on self-regulatory principles as they related to treatment adherence. An outline of topics for the Self-Regulation groups is attached.

Patients randomly assigned to the Support and Discussion arm will also meet in groups of 4-10 participants at their usual hemodialysis clinic for hour-long weekly sessions for seven weeks. Two to four groups will be conducted at each participating center depending on center size. These groups will be also led by a member of the UIHC research team, with each group leader responsible for 3-4 groups over the duration of the project. The Support and Discussion protocol will consist of two integrated components: (a) brief educational materials presented at the start of each session, and (b) group leader facilitated discussion following presentation of the educational materials. An outline of topics for the Support and Discussionn groups is also attached.

Patient adherence to the fluid-intake regimen will be determined by computing the amount of weight a patient gained between dialysis treatment sessions (termed "interdialytic weight gain" or IWG) as recorded in the patient's regular medical record. Mean IWG averaged over two weeks (six sessions) at each assessment point will serve as the primary dependent measure in this study. The pre-enrollment assessment (Time 0) will comprise the two weeks immediately preceding the start of group meetings, Time 1 will comprise the two weeks immediately following the final intervention session, Time 2 will comprise the 12th and 13th post-intervention weeks and the Time 3 assessment will consist of the 25th and 26th post-intervention weeks. Patients will also be asked to complete a previously validated self-report assessment of hemodialysis patient adherence to fluid restrictions (Dialysis Diet and Fluid Non-Adherence Questionnaire). This measure assesses fluid-intake adherence over the previous two weeks and will be obtained on a schedule which parallels the collection of the clinical IWG data.

Study Type

Interventional

Enrollment (Actual)

119

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Iowa
      • Dubuque, Iowa, United States, 52001
        • Tri-State Dialysis
      • Iowa City, Iowa, United States, 52242
        • University of Iowa renal dialysis program

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients will be deemed eligible if they have a mean (averaged over the preceeding four weeks) pre-enrollment, interdialysis weight gain (IWG) greater than 2.5 kg. Other inclusion criteria will include having been receiving hemodialysis for a minimum of three months, patient age over 18 years, and English speaking.

Exclusion Criteria:

  • Patients residing in a nursing home/long-term care facility will be excluded from participation primarily due to likelihood of diminished patient self-management of diet and fluid intake in this setting.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Support and discussion
The Support and Discussion protocol will consist of two integrated components: (a) brief educational materials presented at the start of each session, and (b) group leader facilitated discussion following presentation of the educational materials.
Behavioral: Support and discussion
Seven, weekly hour long group sessions focused on information provision and supportive discussion amongst participants
Experimental: Behavioral Self management
Self-Regulation group sessions will be generally highly leader-directed though participants will be regularly encouraged to share their experiences dealing with the dialysis regimen. A consistent attempt will be made to focus all group discussion on self-regulatory principles as they relate to treatment adherence.Session material utilized by group-leaders will be highly structured and detailed across the seven sessions.
Behavioral: Behavioral self mangement
Seven weekly, hour long group sessions focused on enhancing patient behavioral self management skills.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Interdialysis weight gain
Time Frame: from enrollment to 6 months post-enrollment
from enrollment to 6 months post-enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Iowa

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

February 9, 2010

First Submitted That Met QC Criteria

February 9, 2010

First Posted (Estimate)

February 10, 2010

Study Record Updates

Last Update Posted (Estimate)

May 27, 2015

Last Update Submitted That Met QC Criteria

May 26, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DK72325
  • R01DK072325 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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