Chronic DiseasesNCT01832064
Active Living Tool Kit for Chronic Conditions
A study testing Mailed Chronic Disease Self-Management Program in people with Chronic Diseases, run by Stanford University at 1 site in United States.
Trial summary
The development and pilot testing of a self-management program that would be delivered in a one time mailing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Diseases
- What is being tested?
- Mailed Chronic Disease Self-Management Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 255 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Jul 2014
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a chronic health condition
- 18 years of age
- Literate in English
- (for the blood test subset): have type 2 diabetes
Who cannot join
- Taken the small group or online Chronic Disease Self Management Program or related programs
- under 18
- active cancer treatment
- pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicien
Stanford, California, 94306
About this study
Official title: Development of a Mailed Chronic Disease Self-Management Program
The development and pilot testing of a self-management program that would be delivered in a one time mailing.
Read the detailed description
The mailing will consist of (1) A self-test that will help users know how he or she can best use the materials and where to start; (2) A copy of the 2012 Living Healthy Life with Chronic Conditions book. If people are visually impaired or have low literacy an audio CD of the book will be available in place of the print copy; (3)An exercise CD with flexibility and strengthening exercises at three different levels of intensity, designed for people with chronic conditions; (4) A relaxation CD with three different relaxation exercises; and (5) In addition, there will be tip sheets, one for each major tool such as managing pain, managing sleep, etc. It is expected that there will be 10-20 tip sheets in total.
The key content of the self-test and the tip sheets will be developed surveying master trainers of the existing small-group Chronic Disease Self Management Program (100 active trainers) and asking about 500 additional trainers to rank importance of key content items generated in initial survey. Pilot testing of the program will be by 250 people with chronic diseases. Participants will be surveyed by mailed questionnaires at baseline and six-months. A subgroup with diabetes (estimated 25-30%) will be asked to submit hemoglobin A1C blood test kits at baseline and six months.
- Conditions
- Chronic Diseases
- Being tested
- Mailed Chronic Disease Self-Management Program
- Keywords
- chronic disease, patient education, self management
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mailed Chronic Disease Self-Management ProgramBehavioural
materials are mailed to participants
| Study group | Role | What they receive |
|---|---|---|
| Mailed Chronic Disease Self-Management | Experimental | Mailed Chronic Disease Self-Management Program: self management information and self assessment Receives: Behavioral: Mailed Chronic Disease Self-Management Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Status (symptoms, activity limitation)
Measured: six months
Secondary outcomes (3)
Metabolic control (HbA1c)
For subset of participants with type 2 diabetics
Measured: six months
health behavior (exercise, communication with physician)
Measured: six months
Health care utilization
MD, emergency, hospital times and total nights
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2013 (estimated)
- Study startJun 2013
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic DiseasesStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 255 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kate Lorig, DPH, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01832064
- Sponsor's protocol ID
- 26610
- Status last verified
- Jul 2014
- First submitted
- 11 Apr 2013
- Last updated
- 31 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Mailed Chronic Disease Self-Management Program
- ClinicalTrials.gov ID
- NCT01832064
- Acronym / sponsor ID
- 26610
- Conditions
- Chronic Diseases
- Keywords
- chronic disease, patient education, self management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 255 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 15 Apr 2013 (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 development and pilot testing of a self-management program that would be delivered in a one time mailing.
Detailed description
The mailing will consist of (1) A self-test that will help users know how he or she can best use the materials and where to start; (2) A copy of the 2012 Living Healthy Life with Chronic Conditions book. If people are visually impaired or have low literacy an audio CD of the book will be available in place of the print copy; (3)An exercise CD with flexibility and strengthening exercises at three different levels of intensity, designed for people with chronic conditions; (4) A relaxation CD with three different relaxation exercises; and (5) In addition, there will be tip sheets, one for each major tool such as managing pain, managing sleep, etc. It is expected that there will be 10-20 tip sheets in total.
The key content of the self-test and the tip sheets will be developed surveying master trainers of the existing small-group Chronic Disease Self Management Program (100 active trainers) and asking about 500 additional trainers to rank importance of key content items generated in initial survey. Pilot testing of the program will be by 250 people with chronic diseases. Participants will be surveyed by mailed questionnaires at baseline and six-months. A subgroup with diabetes (estimated 25-30%) will be asked to submit hemoglobin A1C blood test kits at baseline and six months.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mailed Chronic Disease Self-Management | Experimental | Behavioral: Mailed Chronic Disease Self-Management ProgramMailed Chronic Disease Self-Management Program: self management information and self assessment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Have a chronic health condition
- 18 years of age
- Literate in English
- (for the blood test subset): have type 2 diabetes
Key exclusion criteria (4 listed)
- Taken the small group or online Chronic Disease Self Management Program or related programs
- under 18
- active cancer treatment
- pregnant
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 |
|---|---|---|
| Mailed Chronic Disease Self-Management Programmaterials are mailed to participants | Behavioural | Mailed Chronic Disease Self-Management |
Primary outcome
Health Status (symptoms, activity limitation)
Time frame: six months
3 secondary outcomes
Metabolic control (HbA1c)
Time frame: six months
health behavior (exercise, communication with physician)
Time frame: six months
Health care utilization
Time frame: six months
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 31 Jul 2014.
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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.
Kate Lorig, DPH principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mailed Chronic Disease Self-Management Program in people with Chronic Diseases, run by Stanford University 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 31 Jul 2014. 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 Status (symptoms, activity limitation) (time frame: six months). 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 31 Jul 2014.