Chronic DiseaseNCT00013195
Nurse Counseling for Physical Activity in Primary Care Patients
A study testing Telephone Care in people with Chronic Disease and Exercise, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
Many elderly primary care patients are at high risk for health complications and functional impairment due to low levels of physical activity. Previous trials of counseling of elderly patients in primary care clinics have not demonstrated lasting physical activity change and have not evaluated fitness changes… Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Chronic Disease, Exercise
- What is being tested?
- Telephone Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento Jun 2000
- 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 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 60-80 year old patients referred to a walking program by a primary care provider.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
G.V. (Sonny) Montgomery VA Medical Center, Jackson, MS
Jacksonport, Arkansas, 39216
About this study
Many elderly primary care patients are at high risk for health complications and functional impairment due to low levels of physical activity. Previous trials of counseling of elderly patients in primary care clinics have not demonstrated lasting physical activity change and have not evaluated fitness changes associated with any increased activity.
Read the detailed description
Background:
Many elderly primary care patients are at high risk for health complications and functional impairment due to low levels of physical activity. Previous trials of counseling of elderly patients in primary care clinics have not demonstrated lasting physical activity change and have not evaluated fitness changes associated with any increased activity.
Objectives:
The primary objective was to determine if nurse telephone counseling could assist 60 to 80 year old VA primary care patients to establish and maintain a regular walking program.
Methods:
In this randomized clinical trial, 60-80 year old patients were referred to a walking program by primary care providers. All participants received individualized counseling by the nurse and, over the next year, one of three follow-up interventions: 1) 20 calls initiated by the nurse; 2) ten calls initiated by the nurse and ten initiated by an automated telephone message delivery system; or 3) no follow-up calls. All kept walking diaries and mailed these in to a data collector blinded to intervention group. Follow-up research visits were scheduled at six and 12 months. Self-reported walking, the primary outcome measure, was assessed from the walking diaries and validated by reports of significant others and accelerometer data. Improvement in fitness was assessed at 12 months with a standardized six minute walking test. Tinetti mobility scores, body mass index, and body girths were also assessed. Several quality of life measures were also administered.
Status:
Complete.
- Conditions
- Chronic Disease, Exercise
- Being tested
- Telephone Care
- Keywords
- Telephone
- Medical subject headings
- Chronic Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone CareBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Other | Not described Receives: Behavioral: Telephone Care |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2001 (estimated)
- Study completionJun 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Patricia M. Dubbert, PhD, Principal investigator, G.V. (Sonny) Montgomery VA Medical Center, Jackson, MS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00013195
- Sponsor's protocol ID
- NRM 95-022
- Status last verified
- Feb 2007
- First submitted
- 14 Mar 2001
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Dubbert PM, Vander Weg MW, Kirchner KA, Shaw B. Evaluation of the 7-day physical activity recall in urban and rural men. Med Sci Sports Exerc. 2004 Sep;36(9):1646-54. doi: 10.1249/01.mss.0000139893.65189.f2.
PubMed 15354050Dubbert PM, Cooper KM, Kirchner KA, Meydrech EF, Bilbrew D. Effects of nurse counseling on walking for exercise in elderly primary care patients. J Gerontol A Biol Sci Med Sci. 2002 Nov;57(11):M733-40. doi: 10.1093/gerona/57.11.m733.
PubMed 12403802Dubbert PM, Meydrech EF, Kirchner KA, Cooper KM, Bilbrew DE. Encouraging elders to exercise. Federal practitioner : for the health care professionals of the VA, DoD, and PHS. 2001 Jul 1; 18(7):39-59.
Rhudy JL, Dubbert PM, Kirchner KA, Williams AE. Efficacy of a program to encourage walking in VA elderly primary care patients: the role of pain. Psychol Health Med. 2007 May;12(3):289-98. doi: 10.1080/13548500600986559.
PubMed 17510898Cooper TV, Resor MR, Stoever CJ, Dubbert PM. Physical activity and physical activity adherence in the elderly based on smoking status. Addict Behav. 2007 Oct;32(10):2268-73. doi: 10.1016/j.addbeh.2007.01.007. Epub 2007 Jan 11.
PubMed 17275199Cooper KM, Bilbrew D, Dubbert PM, Kerr K, Kirchner K. Health barriers to walking for exercise in elderly primary care. Geriatr Nurs. 2001 Sep-Oct;22(5):258-62. doi: 10.1067/mgn.2001.119470.
PubMed 11606904Dubbert PM, Morey MC, Kirchner KA, Meydrech EF, Grothe K. Counseling for home-based walking and strength exercise in older primary care patients. Arch Intern Med. 2008 May 12;168(9):979-86. doi: 10.1001/archinte.168.9.979.
PubMed 18474762
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nurse Counseling for Physical Activity in Primary Care Patients
- ClinicalTrials.gov ID
- NCT00013195
- Acronym / sponsor ID
- NRM 95-022
- Conditions
- Chronic Disease, Exercise
- Keywords
- Telephone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study completion
- Jun 2000 (actual)
- First posted
- 16 Mar 2001 (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.
Many elderly primary care patients are at high risk for health complications and functional impairment due to low levels of physical activity. Previous trials of counseling of elderly patients in primary care clinics have not demonstrated lasting physical activity change and have not evaluated fitness changes associated with any increased activity.
Detailed description
Background:
Many elderly primary care patients are at high risk for health complications and functional impairment due to low levels of physical activity. Previous trials of counseling of elderly patients in primary care clinics have not demonstrated lasting physical activity change and have not evaluated fitness changes associated with any increased activity.
Objectives:
The primary objective was to determine if nurse telephone counseling could assist 60 to 80 year old VA primary care patients to establish and maintain a regular walking program.
Methods:
In this randomized clinical trial, 60-80 year old patients were referred to a walking program by primary care providers. All participants received individualized counseling by the nurse and, over the next year, one of three follow-up interventions: 1) 20 calls initiated by the nurse; 2) ten calls initiated by the nurse and ten initiated by an automated telephone message delivery system; or 3) no follow-up calls. All kept walking diaries and mailed these in to a data collector blinded to intervention group. Follow-up research visits were scheduled at six and 12 months. Self-reported walking, the primary outcome measure, was assessed from the walking diaries and validated by reports of significant others and accelerometer data. Improvement in fitness was assessed at 12 months with a standardized six minute walking test. Tinetti mobility scores, body mass index, and body girths were also assessed. Several quality of life measures were also administered.
Status:
Complete.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | Behavioral: Telephone Care |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 60-80 year old patients referred to a walking program by a primary care provider.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Telephone Care | Behavioural | Arm 1 |
Primary outcome
Not reported in the source record.
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 7 Apr 2015.
- Results publication: PubMed 15354050Dubbert PM, Vander Weg MW, Kirchner KA, Shaw B. Evaluation of the 7-day physical activity recall in urban and rural men. Med Sci Sports Exerc. 2004 Sep;36(9):1646-54. doi: 10.1249/01.mss.0000139893.65189.f2.
- Results publication: PubMed 12403802Dubbert PM, Cooper KM, Kirchner KA, Meydrech EF, Bilbrew D. Effects of nurse counseling on walking for exercise in elderly primary care patients. J Gerontol A Biol Sci Med Sci. 2002 Nov;57(11):M733-40. doi: 10.1093/gerona/57.11.m733.
- Results publicationDubbert PM, Meydrech EF, Kirchner KA, Cooper KM, Bilbrew DE. Encouraging elders to exercise. Federal practitioner : for the health care professionals of the VA, DoD, and PHS. 2001 Jul 1; 18(7):39-59.
- Results publication: PubMed 17510898Rhudy JL, Dubbert PM, Kirchner KA, Williams AE. Efficacy of a program to encourage walking in VA elderly primary care patients: the role of pain. Psychol Health Med. 2007 May;12(3):289-98. doi: 10.1080/13548500600986559.
- Results publication: PubMed 17275199Cooper TV, Resor MR, Stoever CJ, Dubbert PM. Physical activity and physical activity adherence in the elderly based on smoking status. Addict Behav. 2007 Oct;32(10):2268-73. doi: 10.1016/j.addbeh.2007.01.007. Epub 2007 Jan 11.
- Results publication: PubMed 11606904Cooper KM, Bilbrew D, Dubbert PM, Kerr K, Kirchner K. Health barriers to walking for exercise in elderly primary care. Geriatr Nurs. 2001 Sep-Oct;22(5):258-62. doi: 10.1067/mgn.2001.119470.
- Derived from this study: PubMed 18474762Dubbert PM, Morey MC, Kirchner KA, Meydrech EF, Grothe K. Counseling for home-based walking and strength exercise in older primary care patients. Arch Intern Med. 2008 May 12;168(9):979-86. doi: 10.1001/archinte.168.9.979.
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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.
Patricia M. Dubbert, PhD principal investigator
G.V. (Sonny) Montgomery VA Medical Center, Jackson, MS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telephone Care in people with Chronic Disease and Exercise, run by US Department of Veterans Affairs 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 1 inclusion and 0 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 7 Apr 2015. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00013195, which also lists 7 linked publications.
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 7 Apr 2015.