Chronic ConditionsNCT01122823
Evaluation of the Online Chronic Disease Self-Management Project at Group Health
A study testing chronic disease self-management program (online) in people with Chronic Conditions, run by Kaiser Permanente at 1 site in United States.
Trial summary
The purpose of this study is to learn if Group Health members who participate in the online chronic disease self-management program will experience improved health outcomes, improved health care utilization, and lower costs. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Conditions
- What is being tested?
- chronic disease self-management program (online)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 406 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Jul 2012
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Group Health member
- Have access to Group Health enhanced online services
- one or more chronic conditions or a caregiver of someone who fits that criteria
- 18 years of age or older
Who cannot join
- Not a Group Health member
- No access to Group Health enhanced online services
- No chronic conditions and not a caregiver of someone with a chronic condition
- Under 18 years of age
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to learn if Group Health members who participate in the online chronic disease self-management program will experience improved health outcomes, improved health care utilization, and lower costs.
Read the detailed description
We will pilot an evidence-based online program for chronic disease self-management that is modeled after the widely-replicated in-person Chronic Disease Self-management Program (CDSMP) developed at Stanford University.
The online CDSMP is an internet-based intervention for people with one or more chronic conditions. It is built on self-efficacy theory and is structured around a formal curriculum that emphasizes problem solving, decision making, and confidence building in weekly sessions over six weeks. The curriculum addresses generic topics and skills that are relevant to managing any chronic condition.
The program is structured around three components: 1) password-protected, interactive web-based instruction; 2) web-based bulletin board discussion groups to enable participatory learning and interaction; 3) and a reference book, Living a Healthy Life with Chronic Conditions, that contains the program content and supplemental information. It is facilitated by two trained lay moderators, at least one of whom has a chronic condition.
Piloting the online CDSMP allows Group Health to learn about and maximize the program's impact in the Group Health system before launching a full-scale program. Since web-based interventions are increasingly recognized as holding promise in health care, our learnings and recommendations will likely be applicable beyond this innovation. The pilot provides GH the opportunity to explore the following about the online CDSMP and web-based tools, in general:
- Impact of the online CDSMP on participants' psychosocial and health status, health behaviors, and health service utilization
- Efficient processes for incorporating the online CDSMP into existing operations through use of PDCA cycles
- An understanding of demographic characteristics of members who are more likely to participate in an online self-management program than an in-person program
- Effective recruitment and retention strategies
- Feasibility of sustaining the program without external funding
- Recommendations for successful implementation of future innovations that utilize web-based media, social networking technology, etc.
- Conditions
- Chronic Conditions
- Being tested
- chronic disease self-management program (online)
- Keywords
- Chronic Disease Self-Management Program (CDSMP)
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chronic disease self-management program (online)Behavioural
Also called Healthier Living with Ongoing Health Problems, Chronic Disease Self-Management Program
The online CDSMP is an internet-based program for people with 1 or more chronic conditions. It's built on self-efficacy theory, facilitated by lay leaders, and uses a curriculum emphasizing problem solving, decision making, and confidence building in weekly sessions over six weeks. It addresses generic topics and skills relevant to managing any chronic condition, including: action plans; problem solving; nutrition; exercise; fatigue; breathing; managing medications; managing stress and emotions; working with health care providers. The structure includes: 1) password-protected, interactive web-based instruction; 2) web-based bulletin board discussion groups to enable participatory learning and support; 3) and a reference book that contains the program content and supplemental information.
| Study group | Role | What they receive |
|---|---|---|
| On-line workshop | Experimental | The online CDSMP is an internet-based program for people with 1 or more chronic conditions. It's built on self-efficacy theory, facilitated by lay leaders, and uses a curriculum emphasizing problem solving, decision making, and confidence building in weekly sessions over six weeks. It addresses generic topics and skills relevant to managing any chronic condition, including: action plans; problem solving; nutrition; exercise; fatigue; breathing; managing medications; managing stress and emotions; working with health care providers. The structure includes: 1) password-protected, interactive web-based instruction; 2) web-based bulletin board discussion groups to enable participatory learning and support; 3) and a reference book that contains the program content and supplemental information. Receives: Behavioral: chronic disease self-management program (online) |
What is being measured
The primary outcome is the main question the study is designed to answer.
health outcomes
health status; self-efficacy; activities of daily living; symptomatology; mood; weight
Measured: 6 months and 1 year after the intervention
Secondary outcomes (2)
health care utilization
number of physician visits, number of hospitalizations, number of nights in the hospital (all in past 6 months)
Measured: 6 months and 1 year after intervention
health behaviors
physical activity; stress management; medication adherence; communication with health care team;
Measured: 6 months and 1 year after interventio
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2010 (estimated)
- Study startFeb 2009
- Primary completionJul 2011
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic ConditionsStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 406 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Judith Schaefer, MPH, Principal investigator, Group Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01122823
- Sponsor's protocol ID
- 2008-Innov-4
- Status last verified
- Oct 2017
- First submitted
- 11 May 2010
- Last updated
- 13 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Online Chronic Disease Self-Management Project at Group Health
- ClinicalTrials.gov ID
- NCT01122823
- Acronym / sponsor ID
- 2008-Innov-4
- Conditions
- Chronic Conditions
- Keywords
- Chronic Disease Self-Management Program (CDSMP)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 406 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 13 May 2010 (estimated)
- 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.
The purpose of this study is to learn if Group Health members who participate in the online chronic disease self-management program will experience improved health outcomes, improved health care utilization, and lower costs.
Detailed description
We will pilot an evidence-based online program for chronic disease self-management that is modeled after the widely-replicated in-person Chronic Disease Self-management Program (CDSMP) developed at Stanford University.
The online CDSMP is an internet-based intervention for people with one or more chronic conditions. It is built on self-efficacy theory and is structured around a formal curriculum that emphasizes problem solving, decision making, and confidence building in weekly sessions over six weeks. The curriculum addresses generic topics and skills that are relevant to managing any chronic condition.
The program is structured around three components: 1) password-protected, interactive web-based instruction; 2) web-based bulletin board discussion groups to enable participatory learning and interaction; 3) and a reference book, Living a Healthy Life with Chronic Conditions, that contains the program content and supplemental information. It is facilitated by two trained lay moderators, at least one of whom has a chronic condition.
Piloting the online CDSMP allows Group Health to learn about and maximize the program's impact in the Group Health system before launching a full-scale program. Since web-based interventions are increasingly recognized as holding promise in health care, our learnings and recommendations will likely be applicable beyond this innovation. The pilot provides GH the opportunity to explore the following about the online CDSMP and web-based tools, in general:
- Impact of the online CDSMP on participants' psychosocial and health status, health behaviors, and health service utilization
- Efficient processes for incorporating the online CDSMP into existing operations through use of PDCA cycles
- An understanding of demographic characteristics of members who are more likely to participate in an online self-management program than an in-person program
- Effective recruitment and retention strategies
- Feasibility of sustaining the program without external funding
- Recommendations for successful implementation of future innovations that utilize web-based media, social networking technology, etc.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| On-line workshop | Experimental | Behavioral: chronic disease self-management program (online)The online CDSMP is an internet-based program for people with 1 or more chronic conditions. It's built on self-efficacy theory, facilitated by lay leaders, and uses a curriculum emphasizing problem solving, decision making, and confidence building in weekly sessions over six weeks. It addresses generic topics and skills relevant to managing any chronic condition, including: action plans; problem solving; nutrition; exercise; fatigue; breathing; managing medications; managing stress and emotions; working with health care providers. The structure includes: 1) password-protected, interactive web-based instruction; 2) web-based bulletin board discussion groups to enable participatory learning and support; 3) and a reference book that contains the program content and supplemental information. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Group Health member
- Have access to Group Health enhanced online services
- one or more chronic conditions or a caregiver of someone who fits that criteria
- 18 years of age or older
Key exclusion criteria (4 listed)
- Not a Group Health member
- No access to Group Health enhanced online services
- No chronic conditions and not a caregiver of someone with a chronic condition
- Under 18 years of age
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 |
|---|---|---|
| chronic disease self-management program (online)Also: Healthier Living with Ongoing Health Problems, Chronic Disease Self-Management ProgramThe online CDSMP is an internet-based program for people with 1 or more chronic conditions. It's built on self-efficacy theory, facilitated by lay leaders, and uses a curriculum emphasizing problem solving, decision making, and confidence building in weekly sessions over six weeks. It addresses generic topics and skills relevant to managing any chronic condition, including: action plans; problem solving; nutrition; exercise; fatigue; breathing; managing medications; managing stress and emotions; working with health care providers. The structure includes: 1) password-protected, interactive web-based instruction; 2) web-based bulletin board discussion groups to enable participatory learning and support; 3) and a reference book that contains the program content and supplemental information. | Behavioural | On-line workshop |
Primary outcome
health outcomes
Time frame: 6 months and 1 year after the intervention
health status; self-efficacy; activities of daily living; symptomatology; mood; weight
2 secondary outcomes
health care utilization
Time frame: 6 months and 1 year after intervention
health behaviors
Time frame: 6 months and 1 year after interventio
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2017.
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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.
Judith Schaefer, MPH principal investigator
Group Health Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing chronic disease self-management program (online) in people with Chronic Conditions, run by Kaiser Permanente at 1 site in United States.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 13 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
health outcomes (time frame: 6 months and 1 year after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Oct 2017.